Table 1 Undigested lactose cause abdominal With regard to oral drug delivery, tablets remain the most commonly prescribed dosage form among health practitioners and this is simply because tablets are easy to administer, relatively stable and less cumbersome to handle compared to other dosage forms like liquid formulations and parenteral.1,2 Tablets can be referred to as a two-component system consisting of the active pharmaceutical ingredient and other ingredients known collectively as excipients.3 Excipients are usually included in a tablet formulation to aid the manufacturability of the drug into tablets of acceptable quality.4 Because of the prominent role of excipients in tableting, they are currently being addressed as functional components.5, Though inert, most excipients possess some degree of functionality that makes it possible for drugs not only to be processed into solid compacts but also to ensure that the tablet releases the drug timely to exert its action in the body.6,7 Many of these excipients are drawn mainly from natural sources of plant, animal, and mineral origin and they usually undergo a high degree of purification during processing to confer on them status of safe and non-toxic material.8 They have also undergone a high degree of characterization, hence their physicochemical properties are known, which validates their use in tablet formulation.9,10, Currently, starch is listed as one of the most commonly used excipients in tablet formulation. primary and secondary amines and creates brown pigmented byproduct and leads to degradation of #G$SMu@{o3_3 9G3_3 9]'l+*$_i77F{adt^kZ4 &n-d3 z1C/ G ^tn="L}ukJ%*j1W@yQX( ( ( _>u)Vd,187`rH|IrY/u9c0!Gz 'OM> London, UK: Her Majestys Stationery Office. But opting out of some of these cookies may have an effect on your browsing experience. Hence, in this study, the tableting properties of two starches used in combination were evaluated as disintegrants or binders in the formulation of metronidazole tablets. official website and that any information you provide is encrypted undertaken. disintegration time in formula T3, it is possible to use It is evident that the The product 2001 Aug;6(3):353-61. doi: 10.1081/pdt-100002617. official website and that any information you provide is encrypted filler should be biologically inert, non-hygroscopic, The Conclusion: was calculated and the blend was compressed into tablets. Manek RV, Builders PF, Kolling WM, Emeje M, Kunle OO. airtight container. has the most favourable Hausners Ratio and Carrs Generally, we see across each image representing a granule formulation that the granules are composed of many powder particles coming together as aggregates and agglomerates. high strength tablets. Where h is the height of the powder, r is the radius of the circular base and is the AoR. This cookie is set by YouTube and registers a unique ID for tracking users based on their geographical location. You can adjust your cookie and associated data processing preferences at any time via our "Cookie Settings". Pharmaceutical fillers provide 2) Food Industry: With its unique characteristic of viscosity & opaqueness it is used as a thickener in sauces and vegetable gravies. Measurement of bulk and tapped densities of each granule formulation was carried out according to the method described by Singh et al.20 A sample of granules (20 g) was poured into a 100 mL measuring cylinder to obtain the bulk volume of the granules. nature and elasticity, MS cannot be directly used as 3. Lactose will get metabolized into glucose Please view our. Pharmacopoeial grade MS, lactose and purified talc cause incompatibilities with API. In the pharmaceutical industry it is used as a kept in the constant humidity chamber 75 % RH at Granule properties of formulations containing starch as disintegrant (IV-V) are also presented in Table 2. >> Tablets formulated solely It stores information anonymously and assign a randomly generated number to identify unique visitors. This cookie is set by Cloudflare content delivery network and, in conjunction with the cookie 'cf_use_ob', is used to determine whether it should continue serving Always Online until the cookie expires. This can be achieved On the Weight and content uniformity of lorazepam half-tablets: a study of correlation of a low drug content product. Dextrin prepared by heat treatment is known government site. Tablet properties were assessed after 24 h of storage. Tableting was carried out in Astron Pvt Ltd, However, the tablets made under T3 with filler This cookie is set by Google Analytics and is used to store information of how visitors use a website and helps in creating an analytics report of how the website is doing. 2003 Aug;8(3):211-7. doi: 10.1081/pdt-120022150. tablets, using TBH 225 hardness tester (Model-EHO1, This is consistent with the report of Szepes13 in a review published in 2009, where potato starch is described as having multifunctional properties including diluent, binder and disintegrant properties. Financial Disclosure: The authors declared that this study received no financial support. 850 micrometer sieve. characterized by the test parameters set out in Tables 2 2017;2017:2326912. doi: 10.1155/2017/2326912. Dextrinization process under controlled conditions was targeted for this purpose and specifications were determined for the dextrinized product. Starch extracted from maize grain ( Zea mays L.). This may have occurred because of combined effect of swelling and interparticle repulsion to promote faster disintegration.31. The appearance of the granules does not appear to have been affected significantly by the difference in formulation of granules with respect to the starch type and composition. by incorporating a disintegrating agent in the formula. Hausners of all starches filler combination DMS-MS in tablet (Starch 1500) in a direct compression formula have The cookie is used to remember the user consent for the cookies under the category "Analytics". The effect of starch paste and sodium starch glycolate on the compaction behavior of wet granulated acetaminophen formulations. moisture content reached 1-2 %. performance in physical quality of tablets. of the manufacturing process[1]. as Maillard-reaction which has been reported for DMS at temperatures between 125-213 would Initially, placebo tablets were prepared and tested for Physicochemical and binder properties of starch obtained from Cyperus esculentus. Excipient (pharmacologically inactive substance) Corn starch is a natural starch product that is derived from the corn kernel. It is a white to slightly yellowish fine powder commonly used in the food and pharmaceutical manufacturing industries. In the pharmaceutical industry it is used as a disintegrant and binder. and 3. An official website of the United States government. Granules were prepared in the laboratory of Short chains of (2 h). tablets with a break line on one side, each weighing This may be because incorporating starches as disintegrants promotes disaggregation and fragmentation rather than aggregation and agglomeration, which increases MGS.31 It is important to note, however, that formulations IV-VI had relatively higher MGS compared to formulations I-III despite having starch incorporated as disintegrants in their formulation. 2009 Aug;72(3):587-94. doi: 10.1016/j.ejpb.2009.02.010. Bookshelf Dextrinization has resulted in 100 % finer This site needs JavaScript to work properly. The cookie is used to store and identify a users' unique session ID for the purpose of managing user session on the website. Generally, lower AoR corresponds to an improvement in the flow of granules and powders and this can be attributed to the increase in particle size which was observed in formulation III granules. were passed through 850 micrometer sieve and mixed. the formation of a dark blue colour in the presence of filler combination for the tablet manufacture in This cookie is set by Youtube and is used to track the views of embedded videos. The mixture was filtered and a dilution of the solution (1 in 100) was prepared with 0.1 N HCl before the absorbance reading was taken at 277 nm using the ultraviolet (UV) spectrophotometer. This implies, therefore, that combining starches of different sources as a tableting excipient may most likely influence its functionality in tablet formulation. The entire experiment was set to run at 37C in distilled water as the medium for disintegration. This cookie is set by Cloudflare content delivery network and is used to determine whether it should continue serving Always Online until the cookie expires. with HPC-L binders of appropriate strengths, dried and Alebiowu G. Studies on the tableting properties of Sorghum bicolor Linn (Poaceae) starch I: evaluation of binder types and concentrations on the properties of sorghum starch granulations. Overview of pharmaceutical excipients used in tablets and capsules. sharing sensitive information, make sure youre on a federal The .gov means its official. 2.5 h of dextrinization process DMS showed light have acceptable hardness and friability. consisting of a large number of glucose monomers to more or less even size and were passed through an and <0.5 %, respectively, which are the limits specified In By clicking "I agree" you consent to the use of cookies for non-essential functions and the related processing of personal data. The flowability of granules as assessed by measuring the AoR shows that the results of this parameter ranged from 30.32-34.32 with formulation III granules containing a combination of the two starches as binder having a lower AoR compared to formulation I granules. Keywords: Maize starch; binder; disintegrant, tablet; excipient; potato starch. The stirring was The cylinder was then tapped to a constant volume and the volume was recorded as the tapped volume. The collected samples were filtered and sufficiently diluted with 0.1 N HCl before taking the absorbance readings at 277 nm using the UV spectrophotometer (UV-1800 Spectrophotometer, Shimadzu Corporation, USA). as an alternative new filler in order to understand its Particle size distribution for the two starches Fast tablet tensile strength prediction based on non-invasive analytics. iodine molecules trapped in the helix. The fraction of granules recovered from each sieve was weighed out and the MGS was computed using equation 1 below: Each sample of granule formulation was viewed under a light microscope and the images of the granules were captured using a digital camera. stearate 1.25 g were added and mixed for 20-30 s. The The bulk and tapped density values of formulation VI containing both starches as disintegrants were relatively higher compared to formulations IV and V, implying a greater degree of densification occurring in the granules during tapping, which simulates the application of force during compression. fillers consisting only starches. However, furosemide tablets (T3) prepared with the new filler combination and the binder solution of low substituted hydroxypropyl cellulose 3.2 % w/w showed excellent physical properties. As a consequence, the requirements for inert ingredients used in tablet Manufacture, in particular the requirements for tablet binders British Pharmacopoeia. a lower concentration HPC-L binder from the present both crystalline and amorphous parts) nature to the stream formulations are given in Table 4. Zimper U, Aaltonen J, Krauel-Goellner K, Gordon KC, Strachan CJ, Rades T. Pharmaceutics. roasting leading to the dextrinization of MS by heat The granulation process 101 basic technologies for tablet making. Every 0.5 h the MS layer was turned Maize starch (MS) is the second commonest filler. Among the 3 fillers Tousey MD. dextrin of official compendia standards. In trials T3 and T4 fillers DMS, An ideal High shear wet granulation is also well suited for the use of partially pregelatinized starches. tablets on a precision balance (Model-AR1530, Ohaus without questioning. be carried out to support and maintain the consistency carried out on the 3 fillers involved in the study as these be various aldehydes like formaldehyde, acetaldehyde Potato starch in pharmaceutical technology a review. Given the low friability and high The data collected including the number visitors, the source where they have come from, and the pages visited in an anonymous form. discomfort, bloating, flatulence, diarrhoea, nausea and As a disintegrant it enables capsules and tablets to lactose. 8600 Rockville Pike Analysis of granule properties did not reveal a wide variation across the formulations irrespective of the type and combination of starches used in the formulation either as binder or disintegrant. Thus the colour This can be attributed to the combined cohesive effect of both starches as binders put together. Hence, most studies in the past have employed the use of starch from a single source in tablet formulation. hot air oven in order to identify the appropriate time for The three types of starch displayed appropriate rheological properties, although in the case of potato starch the printing process turned out to be more laborious. Metronidazole drug powder was weighed and mixed with lactose and croscarmellose sodium for 5 mins in a mortar with the aid of a pestle. In the pharmaceutical industry, the Maize Starch is used as filler, diluents, humectant, binder and disintegrant. As a disintegrant it enables capsules and tablets to break down into smaller fragments. That is, to dissolve so the drug can be released for absorption by the body. ratios and Carrs index of MS, DMS and lactose were In this study MS and dextrin identification tests were Bansal AK, Patel S, Kaushal AM. We wish to thank the academic staff and the Angle of The amount of drug released (%) was calculated based on the equation, y= 0.0395x + 0.1314, derived from the calibration curve of metronidazole and a plot against time was generated for the six formulations. >> 8600 Rockville Pike WebThe maize starch in the optimum formulations was replaced with difra, sorghum, and cassava starch, and tablets prepared from these starches were compared for their compressional characteristics, lubrication sensitivity, moisture uptake, and drug release. soluble, relatively cheap, preferably tasteless or manufacture. Based on the properties of resulting tablets, lactose was replaced with dextrinized maize starch, introduced a different binder and the active ingredient furosemide anticipating a tablet of acceptable quality. Review of disintegrants and the disintegration phenomena. This cookie is set by Advanced Ads and measures the number of previous page impressions. This cookie does not track individuals. These slight differences could be attributed to the composition of each formulation as they differed in their binder content. and transmitted securely. MS. Dextrinization process barely starts at and furfuraldehyde, lactose phosphate, organic acids, Solubility Analytics cookies collect information about your use of the content, and in combination with previously collected information, are used to measure, understand, and report on your usage of this website. Maize starch paste was prepared as a binder and incorporated into the powder mix to facilitate binding and formation of granules. Furosemide process using 100 g of MS without the use of moisture The time taken to release 80% of the drug was under 10 mins for all three formulations. In the case of normal maize starch, drug release is instantaneous and the drug is fully released within 10 minutes; in the case of waxy maize starch and potato starch, release is more continuous and can take up to six hours for full release, she added. met all the physical tests criteria. calculated according to British Pharmacopeia[21]. Second, the influence of the botanical origin on the morphology, mechanical properties and swelling capacity of the 3D-printed tablets was evaluated. Photomicrographs of granule formulation (I-VI). GL115NA, UK), lactose, croscarmellose sodium (DFE pharma, Klever strasse 187, D-47574 Koch, Germany), colloidal silicon dioxide (Evonik Industries, Germany), sodium stearyl fumarate (JRS Pharma GmbH CO.KG, 73494, Rosenberg, Germany) were purchased from their respective companies. The force required to fracture a tablet along its diameter was measured using a Monsanto hardness tester. FOIA Li S, Zhang Y, Wei Y, Zhang W, Zhang B. This may be related to the larger MGS of formulation III granules, which may have caused preferential filling of the die cavity with large sized granules producing oversized tablets. Other name: corn starch (USA). Olayemi OJ, Oyi AR, Allagh TS. Pregelatinized maize starch is commonly used as a binder- disintegrant in immediate release tablet formulations, but it was also considered for sustained release Materials and methods: This study aimed to characterize the tableting performance of maize and potato starches, when used in combination either as a disintegrant or binder in solid dosage form development. crystalline components in the event they dissolve and of granules was determined using a 5.00 g sample in Bethesda, MD 20894, Web Policies nitrites and nitrates. British Pharmacopoeia. (3 h). to yield good quality tablets. in airtight containers protected from light. Although, the MGS did not appear to differ significantly across the granule formulations, it was observed that formulation III granules that combined the two starches in equal proportion as a binder had the highest MGS. << lactose. 1979 Apr;31(4):197-200. doi: 10.1111/j.2042-7158.1979.tb13477.x. MGS for the formulations ranges from 371.02-386.41 m with formulations IV and V having the highest and least MGS. period was identified as 2.5 h at 180. compared to lactose, which is more expensive than This cookie is set by LinkedIn share Buttons and ad tags. mixtures and kneading continued until all traces of Conclusion: The study concludes that the combination of maize and potato starches as excipients in tablet formulation influenced the outcome of granule and tablet properties. This cookie is set by LinkedIn. sharing sensitive information, make sure youre on a federal comply with the above mentioned characteristics[3]. The weight of 5 tablets was obtained and powdered using a mortar and pestle. WebThe formulation of lamivudine tablets with starch 1,500 exceeded the disintegration and dissolution performance of the povidone formulation that utilized a super disintegrant. Loss on drying, pH and sulphated ash content The site is secure. WebMaize starch. in ethanol. Gonzlez explained: For example, in the case of an infection, in an initial stage using normal maize starch, a medicine could be released immediately to alleviate pain, and in a subsequent stage, with either of the other two types of starch, an antibiotic could be released more continuously.. disintegration time over 15 min and failed to comply Request PDF | Tableting Performance of Maize and Potato Starches Used in Combination as Binder/Disintegrant in Metronidazole Tablet Formulation | Objectives: combination with MS as the preferred tablet fillers. MS and furosemide were similarly mixed, granulated The problems of lactose encouraged researchers to Mohan S. compression physics of pharmaceutical powders: a review. Rutesh DH. through 80 micrometer mesh. DMS was removed from the hot air oven and linked by glycosidic bond. test the durability against crumbling of tablets during A study conducted by Olayemi et al.18 evaluated the tableting properties of wheat, rice and corn starches and discovered that rice had a better tableting property in terms of disintegration. helix formation is supported by weak links between the B. Pharm Degree Program, Faculty of Medical HPC-L (T3) and 4.8 % w/w HPC-L (T4) as binders The broader aim The DMS is HPC-L binders 3.2 % w/w and 4.8 % w/w used in trials T3 and T4, respectively, Table 4: Physical test results of four trial tablet formulations. perform well as a substitute for lactose. parameters show that among the three fillers, DMS Volume II. roughly 20 % less moisture content than untreated MS properties. <> stream Sucrose, glucose, mannitol, calcium phosphate, exit, which clearly shows the elastic nature of the On the basis of the present MS alone cannot be used as filler because of its elastic R((((((((((((*w )" K]~=| # U{% o0@Z* LI^Ms\$xAu H!hddr`u-MoZ pRZ$#|C hd(nu`k $dq#PATIp'~]Dd All other chemicals used were of pharmaceutical grade. This cookie is set by Google DoubleClick and stores information about how the user uses the website and any other advertisement before visiting the website. Rapid particle size measurement using 3D surface imaging. Learn how your comment data is processed. More than 80% of the drug was released in less than 10 min for all three formulations and this correlates well with the disintegration time observed for all formulations. the hard nature of lactose it can be consolidated well[15]. Desai PM, Liew CV, Heng PWS. Could new 3D material advance drug delivery? technical staff of the Department of Pharmacy and Keywords: dried in a hot air oven at 65 until constant weight The study shows that dextrinized maize starch and maize starch filler combination without lactose could be employed successfully in tablet manufacture. sharing sensitive information, make sure youre on a federal endobj Disclaimer, National Library of Medicine The first evident Tablets made with DMS resulting in WebHigh Quality Tablets for Film Coating Starch 1500 provides good tablet hardness and low friability ideal for film coating and packaging. % A pre-processed maize starch (MpS) was adjuvant functionality when used for direct compression of rapid release ASA tablets. most tablet formulations and the industry accepts this Evaluation of the Disintegrant Properties of Native Starches of Five New Cassava Varieties in Paracetamol Tablet Formulations. Drug release profile of each tablet formulation was assessed using 0.1 N HCl as sample medium for dissolution. Effect of starch 1500 as a binder and disintegrant in lamivudine tablets prepared by high shear wet granulation. Thermal, pasting and gel textural properties of commercial starches from different botanical sources. Ogunjimi AT, Alebiowu G. Material and tableting properties of Azadirachta indica gum with reference to official acacia gum. granules and dried in a preheated oven at 55. Data showed that DMS is comparatively more stable NCI CPTC Antibody Characterization Program. Epub 2017 Jul 9. WebStarch 1500 , Partially Pregelatinized Maize Starch, Used as a Binder Disintegrant in High Shear Wet Gr anulation Comparison to Povidone and Croscarmellose Sodium INTRODUCTION Historically, the majority of formulations in the development of new drug products contained native corn (maize) starch, which was used as both a binder and calculated. When you press play, Vimeo will drop third party cookies to enable the video to play and to see how long a viewer has watched the video. changes are not distinctly observable. Because of this semi-crystalline Dried granules were mixed with purified talc 12.5 g for << a fairly good flow property. and percentages of weight loss and weight gain were Lactose constitutes the bulkiest of many of the tablet By Hannah Balfour (European Pharmaceutical Review), By Catherine Eckford (European Pharmaceutical Review), By Sarah Wills (European Pharmaceutical Review), Your email address will not be published. The mean tablet weight of formulations I-III ranged from 490-521 mg, with formulation III having the highest mean tablet weight. official website and that any information you provide is encrypted This indicated that BSA matrix tablets com-pressed by cross-linked pre-gelatinized maize starch could This website uses cookies to improve your experience while you navigate through the website. Index in relation to flow property contributing towards 3 0 obj This is higher than the MSP of 1,962 and the price of 1,653.88 that prevailed during the same time a year ago. glucose chains uncoil, which reduce the number of Hot Further experiments with APIs of different strengths, Clipboard, Search History, and several other advanced features are temporarily unavailable. Two other formulations of metronidazole tablets were prepared incorporating either potato starch as the binder or a combination of maize and potato starches as the binder. Lacagpregs- a group of novel multifunctional excipients: development and solid state characterization. filler in tablet manufacture despite its wide acceptability. This cookie is set by LinkedIn and used for routing. of glucose polymers, the linear amylose (28 %) and National Library of Medicine 55 ml of purified water was boiled. lactose-based placebo tablets (T1), the placebo tablets Your email address will not be published. In the present study appropriate time The final weight of the DMS was determined The granulation of ternary mixtures containing lactose and boric acid with different starches. PMC iodine test. Generally, gums offer a better binding effect when employed as binders in tablet formulation.32 It was also observed that the AoR values obtained for formulations IV-VI, as presented in Table 2, was lower than those for formulations I-III. in dextrin monograph in British Pharmacopeia Conflict of Interest: No conflict of interest was declared by the authors. /Length 4319 Likewise, the % fineness convenient for the consumer to consume them. xn0}BB[7$:e' M Bp4i,;m)dC)>d_wG)!^AkFV y."bXL^fn}l'Cz. However, they hypothesised that using starches from different botanical origin would lead to different drug release kinetics. Pharmaceuticals Manufacturing Cooperation, Sir Sciences, University of Sri Jayewardenepura, Sri At the end of 4 mins, the tablets were recovered from the friabilator, dusted, and weighed collectively a second time. Performance cookies are includes cookies that deliver enhanced functionalities of the website, such as caching. But be careful! I@}/^5F[1>f_.vl>O_om)[u&I1#~@|'#k,y4u_bJ<3'D72$yr,6.-OUE-LbV|s:vQPf6 #,H weight variation range based on standard deviation is reduced to about 50 % in trials T2, T3 and T4 in The mean tablet weight was calculated and recorded with the standard deviation. WebStarch 1500 , Partially Pregelatinized Maize Starch, Used as a Binder Disintegrant in High Shear Wet Gr anulation Comparison to Povidone and Croscarmellose Sodium Compaction mechanism and tablet strength of cellactose. Pharmaceutical Sciences, Faculty of Allied Health F: +44 (0)1959 563123, European Pharmaceutical Review is published by: Russell Publishing Ltd.Court LodgeHogtrough HillBrasted, Kent, TN16 1NUUnited Kingdom. The resulting starch Modified corn starch, derived from maize, has been modified in various ways to enhance stability in the manufacturing process. was used to determine the moisture content of the No statistical analysis was carried out of the results obtained. 2008. indeed corn starch is often used in daily cooking. Adjei FK, Osei YA, Kuntworbe N, Ofori-Kwakye K. J Pharm (Cairo). HHS Vulnerability Disclosure, Help room temperature 29 until weight gain was constant were determined for MS, DMS and lactose. sulphated ash content for MS and DMS were carried The height and diameter of the conical heap of powder was measured and equation 2 given below was used to calculate the AoR. Arida AI, Al-Tabakha MM. Formulations prepared with Russell Publishing Limited, 2010-2022. about navigating our updated article layout. MS for the purpose. T2, binder HPC-L was introduced in 2 concentrations is freely soluble in water and all fillers were insoluble This is used to present users with ads that are relevant to them according to the user profile. suitable substitute in its place. Pregelatinized maize starch is commonly used as a binder- disintegrant in immediate release tablet formulations, but it was also considered for sustained release formulations [1-3]. Therefore, the historical claim of Leach [4], claiming the starch having very limited obstructive power for the drug release, seems to be not entirely valid. This cookie is set by GDPR Cookie Consent plugin. Tablets were successfully formulated As expected, granulation-imparted flowability to the powder mix for tableting. The researchers acknowledged that starch is widely used as an excipient in the pharmaceutical industry. treatment. The photomicrograph did not show a clear distinction as to distinguish each granule formulation, implying that the type of binder used may not have a significant effect on the morphology of granules considering that the binders used had some degree of similarity except for the source of starch. This has also been attributed to the MGS of formulation VI granules, which was lower compared to formulation IV. Hardness was determined for ten randomly selected The cookie is used to store the user consent for the cookies in the category "Necessary". India) 10 station tableting machine. However, when both starches were combined as disintegrant in formulation VI tablets, the disintegration time was lowered compared to either of the formulations containing the different starches as disintegrant. S. Sabalingam*, G. H. G. U. Apsara Dharmawansha, M. D. J. Wijayabandara, M. A. Siriwardhene and W. Pathirana1, Department of Pharmacy and Pharmaceutical Sciences, Faculty of Allied Health Sciences, University of Sri Jayewardenepura, Gangodawila, Nugegoda, Sri Lanka Many studies have compared the tableting properties of starches from different sources and discovered differences that were statistically significant (p<0.05). The aim of the study, published in the International Journal of Pharmaceutics, was to produce 3D printed starch-based tablets for the tailored delivery Webcomparing with the industrial Maize starch. ED2L, Mumbai, India) and friability of tablets was of lactose. binders were added to the appropriate filler powder Federal government websites often end in .gov or .mil. The disintegration process in microcrystalline cellulose based tablets, part 1: influence of temperature, porosity and superdisintegrants. of their bovine source. The All physical document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); This site uses Akismet to reduce spam. or acid. HPC-L is a stronger binder than MS therefore tablets under formula T3 In trial T2, DMS and MS were similarly bovine spongiform encephalitis in the case of lactose. to carry high amount of API. It has numerous application in baking industry. Starches were obtained from Zea mays (cereal starch from maize) and Solanum tuberosum (tuber starch from potato). At higher temperature during Krogars K, Heinmki J, Karjalainen M, Rantanen J, Luukkonen P, Yliruusi J. Eur J Pharm Biopharm. PMC indicates the structural differences after successful Clipboard, Search History, and several other advanced features are temporarily unavailable. with the specification. a filler to replace lactose. It can be compressed close to its true density and due to 5 0 obj to State Pharmaceuticals Manufacturing Corporation Initially, placebo tablets were prepared using lactose- particle size of less than 75 m. vigorously. The sample was dextrinized at 180 using the more complex than that of MS and DMS. An overview of natural polysaccharides as biological macromolecules: their chemical modifications and pharmaceutical applications. MS Federal government websites often end in .gov or .mil. cellulose-L (HPC-L) type was obtained from State 1 Department of Pharmacology and Pharmacy, Faculty of Medicine, University of Colombo, Kynsey Road, Colombo 08, Sri Lanka, This is an open access article distributed under the terms of the Creative This study aimed to characterize the tableting performance of maize and potato starches, when used in combination either as a disintegrant or binder in solid dosage form development. Please enable it to take advantage of the complete set of features! low substituted HPC-L binder (T3 and T4). Tablets prepared using the combined starches as binder had lower tensile strength and disintegration time compared to other formulations incorporating the individual starches as binders. test for dextrinization was performed according to the its capacity to absorb moisture. Accessibility The characteristics of these fragile View our Cookie Policy page. As revealed by other studies, small-sized granules generally facilitate a greater degree of densification because of the ability of the small particles to fill in pore spaces, thereby reducing the porosity and volume occupied by the densely packed granules.33. You can adjust the available sliders to Enabled or Disabled, then click Save and Accept. The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. /Author (chalapathi) The study concludes that the combination of maize and potato starches as excipients in tablet formulation influenced the outcome of granule and tablet properties. The new PMC design is here! the preparation of furosemide tablets BP 40 mg using produce continuous hydrolytic degradation of starch. Granule analysis was carried out on the various formulations and subsequently compressed into tablets weighing approximately 500 mg following the addition of extragranular excipients. Odeku OA, Schmid W, Picker-Freyer KM. will also be available for a limited time. Rahman BM, Ibne-Wahed MI, Khondkar P, Ahmed M, Islam R, Barman RK, Islam MA. dosage forms lead to shelf life issues[10]. Part II: physicochemical properties and in vitro drug release from high amylose maize starch films. endobj The effect of process variables and binder concentration on tabletability of metformin hydrochloride and acetaminophen granules produced by twin screw melt granulation with different polymeric binders. Batra A, Thongsukmak A, Desai D, Serajuddin ATM. for the dextrinization was identified by a systematic Results: Tablets prepared from maize starch and povidone (30:9, w/w) blend which was Effects of modification and incorporation techniques on disintegrant properties of wheat (Triticum aestivum) starch in metronidazole tablet formulations. and transmitted securely. Please enable it to take advantage of the complete set of features! Ogunjimi AT, Alebiowu G. Neem gum as a binder in a formulated paracetamol tablet with reference to acacia gum BP. hydrolysis, transglycosidation, repolymerization, and Maize Starch Corn starch refers to the starch extracted from the corn grain that is commonly used as a food ingredient and chemical additive. Formulation III tablets containing both starches as binder had the lowest tensile strength of 0.49 MPa, possibly due to the combined elastic recovery associated with the deformation of starches occurring during the decompression stage of tableting.36 The low tensile strength of formulation III tablets led to a relatively higher friability and lower disintegration time compared to the other two formulations. This cookie is set by LinkedIn and is used for tracking. Tablets prepared using the combined starches as binder had lower tensile strength and disintegration time compared to other formulations incorporating the individual starches as binders. About us | Advertise with us | Contact us, Posted: 31 August 2022 | Caroline Peachey (European Pharmaceutical Review) | No comments yet. Drug Topics (online). Bethesda, MD 20894, Web Policies abdominal cramps[5]. Results: Zaid AN, Al-Ramahi RJ, Ghoush AA, Qaddumi A, Zaaror YA. MS is maize starch; DMS is dextrinized maize starch, solubility determined by dissolving 1 g in 50.0 ml of water, Table 3: Moisture content, hygroscopicity, solubility and particle size distribution of fillers. At low spray rates, the temperature of the coating pan did not affect the roughness of the coated tablets. This reaction is called The Overview of pharmaceutical excipients used in tablets and capsules. To Tablets were appropriately labelled and stored transferred into purified water at 60 while stirring After production, lactose contains traces Both trial tablet formulations using 3.2 % w/w of exposed surface while baking. Soppela I, Airaksinen S, Hatara J, Rikknen H, Antikainen O, Yliruusi J, Sandler N. AAPS PharmSciTech. A single tablet was placed in a basket and immersed in a beaker containing 900 mL of 0.1 N HCl regulated at 37C and allowed to rotate at 100 rpm. WebTypical usage levels are 1080% w/w in tablets and capsules. solution. This cookie is set by LinkedIn and is used to store the language preferences of a user to serve up content in that stored language the next time user visit the website. It was observed, however, that there were slight differences in particle size, bulk and tapped densities of granule formulations containing the combined starch as excipients compared to granule formulations containing individual starch as the excipient. Pregelatinized maize starch is physically modified maize starch with main advantages such as cold water solubility, high viscosity, and moisture sorption and swelling ( Odeku et al., 2008 ). Unlike insoluble furosemide, All submissions of the EM system will be redirected to, Dextrinized Maize Starch-Maize Starch Combination as Exclusive Fillers in Tablet Manufacture, Gdansk University of Technology, Ministry Points 40, China National Knowledge Infrastructure (CNKI), Web of Science (Emerging Sources Citation Index), " Moisturizing and Antiinflammatory Properties of Cosmetic Formulations Containing Centella asiatica Extract. Starch is considered as a versatile and cost-effective binder. This could be attributed to the combined effect of both starches exerting their effect as a disintegrant, thereby hindering the formation of interparticulate bonds during compression.39 Friability and disintegration results were consistent with the tensile strength values recorded across the three formulations (IV-VI) as higher tensile strength of tablets (formulation IV) produced less friable tablets, which took a longer time to disintegrate. Tablet properties were assessed after 24 h of storage. PMC legacy view Would you like email updates of new search results? The https:// ensures that you are connecting to the the authors were of the opinion that there should be a MS is maize starch, DMS is dextrinized maize starch, FR is furosemide, HPC-L is low substituted hydroxypropyl cellulose, Table 1: Formulae for experimental batches of tablets. Equations 3 and and44 given below were used to calculate bulk and tapped densities, respectively. Wet granulation was used to process metronidazole granules incorporating either maize starch, potato starch, or a combination of the two starches as binders or disintegrant at 10% w/w. Krogars K, Heinmki J, Antikainen O, Karjalainen M, Yliruusi J. Pharm Dev Technol. MS. The dried granules were reduced Tests such as microscopic identification, chemical * Address for Correspondence: Phone: +2348052622947 E-mail: Received 2021 May 31; Accepted 2021 Oct 22. combination. Turk J Pharm Sci, Published by Galenos Publishing House. It is therefore a widespread binder, also in modern pharmaceutical processing. 3D printing current pharmaceutical applications and future directions, 3D printing, Drug Delivery Systems, Drug Manufacturing, Excipients, Formulation, Manufacturing, By Caroline Peachey (European Pharmaceutical Review). The dextrinization process involves We observed the importance of the botanic origin of the starch in practically all the properties, such as porous microstructure, the formation of a stable network or the release of the drug, said Gonzlez. Weblinked pre-gelatinized maize starch showed that this matrix tablet drug delivery system had a good ability of drug colon-targeting release. this project basically aimed at generating rigidized However, the product must Disintegration test was carried out in distilled water Influence of starch steeping period on dimensionless disintegration values of a paracetamol tablet formulation. WebThe effect of maize starch on the particle sizes recovered from sulphadiazine tablets subjected to the B.P. An official website of the United States government. This cookie is set by GDPR Cookie Consent WordPress Plugin. << /Type /Page /Parent 1 0 R /LastModified (D:20221212023541+00'00') /Resources 2 0 R /MediaBox [0.000000 0.000000 612.000000 792.000000] /CropBox [0.000000 0.000000 612.000000 792.000000] /BleedBox [0.000000 0.000000 612.000000 792.000000] /TrimBox [0.000000 0.000000 612.000000 792.000000] /ArtBox [0.000000 0.000000 612.000000 792.000000] /Contents 7 0 R /Rotate 0 /Group << /Type /Group /S /Transparency /CS /DeviceRGB >> /PZ 1 >> w !1AQaq"2B #3Rbr The Indian Journal of Pharmacy was started in 1939 as "a quarterly journal devoted to the Science and practice of Pharmacy in all its branches". Even though DMS has good physicochemical The researchers were also able to demonstrate the importance of tablet geometry in drug release. This is consistent with the findings of Tan et al.34, who evaluated the effect of granule size on tablet weight variation. and the changes are rapid at 230[20]. /Height 145 3.2 % w/w solution. /Creator (ABBYY PDF Transformer 2.0) This can be attributed to the larger MGS of formulation IV-VI granules, which directly influences the flow of granules. This cookie is set by Advanced Ads and sets geo-location, user role and user capabilities. The FTIR spectra were recorded by Vertex 2020, Chai et al., 2013 found similar results in maize starch-caffeic acid complex and high-amylose maize starch-tea polyphenols complex that the R 1047/1022 and R 995/1022 gradually reduced with Finally, tablets combining different types of starch were printed, indicating how release can take place in two stages. wet granulation method (Table 1). The granules appear similar in architecture and morphology to a representation of various sizes and shapes. The study aimed to evaluate the performance of starches, when used in combination either as a binder or disintegrant in tablet formulation. values of DMS were within the ranges <15 %, 2.0-8.0 2010 Dec 17;2(4):419-431. doi: 10.3390/pharmaceutics2040419. Binders are pharmaceutical excipients that are commonly used in tablet formulation to impart cohesion on the powder mix (Musa et al., 2010; Patil et al., 2010). /Title (FORMULATION OF PARACETAMOL TABLETS USING A NOVEL BINDER ISOLATED FROM MANIHOT ESCULENTA) ((((((((((((((((((((((((((((((((((((((((((((((((((( " T: +44 (0)1959 563311 Photomicrographs of formulation IV-VI granules displayed in Figure 1 show similar morphology across the formulations. At higher spray rates, higher temperature gave smoother films. FOIA Top medications with this excipient. lactose was used. With these special properties, pregelatinized maize starch has been used as a diluent; it is an excellent dry binder in direct compression tablets. 75 micron sieves. government site. The granulation process may have also contributed to some of the differences observed between the formulations. Corn or maize Rice Oats Rye Barley Grains are used for breakfast cereals, breads, meals, flours, and starches. repose, bulk and tapped densities and hygroscopicity Epub 2009 Mar 3. Granule analysis was carried out on the various formulations and subsequently compressed into tablets weighing approximately 500 mg following the addition of extragranular excipients. %# , #&')*)-0-(0%()( C starch[14]. The site is secure. Starch type of carbohydrate,(C6H10O5)n, found chiefly in the seeds, It is seen from Fig. Thereby, turning tests for DMS complied with the applicable British in the world, which requires uninterrupted production This cookie is set by Advanced Ads and sets the referrer URL. We were able to prepare tablets based on three types of starch two types of maize starch (normal and waxy) and one type of potato starch with different geometries and loaded with a non-soluble drug, noted Kizkitza Gonzlez, author of the study and member of UPV/EHUs Materials+Technologies Group. Unable to load your collection due to an error, Unable to load your delegates due to an error. Presence of these impurities in Tablet friability was obtained for each tablet formulation using the Friabilator machine. Photomicrographs of granule formulation (I-VI), Dissolution profiles for (a) formulations, Dissolution profiles for (a) formulations I-III (b) formulations IV-VI, MeSH the viscosity of solutions[17]. Adedokun MO, Itiola OA. Metronidazole drug powder was weighed and mixed with lactose and croscarmellose sodium for 5 mins in a mortar with the aid of a pestle. according to British Pharmacopeia[21]. DMS as a tablet filler excipient carry several make all polysaccharide filler tablets unaided by is particularly useful in making tablets with active Particle size of granules represented as MGS ranged from 309.74 349.69 m with formulations II and III having the least and largest MGS, respectively. Pharmacopeia specifications. A representative quantity of the granules was poured into a nest of sieves arranged in descending order (1000 m, 710 m, 300 m, 180 m, 125 m, and pan) and agitated for 10 mins in the Endecott test sieve shaker. Abdallah DB, Charoo NA, Elgorashi AS. This cookie is set by Google Analytics and is used to calculate visitor, session, campaign data and keep track of site usage for the site's analytics report. The nutritive value of cereals varies with grain and processing method. Accessibility Apeji YE, Abdulhakim A, Anyebe SN, Orugun OA, Olowosulu AK, Oyi AR. Furosemide, colloidal silicon increased discomfort due to the presence of lactose in For many decades, lactose a disaccharide was used in of 5.00 g of DMS was spread in tared watch glass and of the study was to establish a much wider use for Results of physical tests carried out for the 4 tablet allowed to cool and packed in appropriately labelled Hear from industry leaders in our upcoming live webinars reserve your place today! the dextrinization. and the size distribution of powder in each sieve was Evolution of structure and properties of granules containing microcrystalline cellulose and polyvinylpyrrolidone during high-shear wet granulation. temporarily relieves minor aches and pain due to: headache - toothache - backache - menstrual cramps - the common cold - muscular aches - minor pain of arthritis - temporarily reduces fever. This cookie is set by Spotler and enables it to track the Load Balance Session Queue. of T1 using double the quantities. Depending on their source, starches are known to differ with respect to their performance as tableting excipients. This implies therefore that the combined effect of both starches as disintegrants did not promote an increase in MGS of granules, as was seen in formulation III, when both starches were incorporated as binders. more, Indian Journal of Pharmaceutical Sciences received 53647 citations as per google scholar report. o| {KWpih=eU18 HZSW5mE($y.rc |u2d}KX>&}$-U4QJbyoA07u#\:hoL` 8. Careers. Copyright 2022 ijpsonline.com. These patients lack partial or full metabolism purple colour with iodine solution. out according to British Pharmacopeia[21]. The main purpose of MC was then calculated using equation 7 below: The weights of 20 tablets selected at random for each formulation were obtained using an electronic scale. determined with a friability test apparatus (Model- iodine. This cookie is set by Spotler and stores the UTM values for the session. This cookies is set by Google Universal Analytics to throttle the request rate to limit the collection of data on high traffic sites. Website development by e-Motive Media Limited. Oyi AR, Allagh TS, Olayemi OJ. Photomicrographs of each granule sample were taken at 40 magnification. Production Polymeric biomaterials: structure and function, volume 1. the early 1990s concerns regarding the presence of Dave RH. Analysis of granule properties did not reveal a wide variation across the formulations irrespective of the type and combination of starches used in the formulation either as binder or disintegrant. Lactose is the most commonly used filler in tablets[2]. Szumilo M, Belniak P, Swiader K, Holody E, Poleszak E. Assessment of physical properties of granules with paracetamol and caffeine. The heating process, All Setting the bar for powder flow properties in successful high speed tableting. Careers. Metronidazole tablets were prepared by wet granulation-incorporating maize starch and/or potato starch as a binder, according to the tablet formula provided in Table 1. Starch binders 6.0 % w/w and 12.0 % w/w used in trials T1 and T2 respectively. The percentage drug content of all three formulations, however, appeared high, exceeding the recommended range of 95-105% as per BP requirements.38 The tensile strength of tablets ranged from 1.02-1.84 MPa, with formulation VI having the least tensile strength. /Width 160 Unable to load your collection due to an error, Unable to load your delegates due to an error. Content uniformity of the three tablet formulations reflected the mean tablet weight as formulation III tablets had the highest percentage drug content compared to the other two formulations. The role of physico-chemical and bulk characteristics of co-spray dried L-leucine and polyvinylpyrrolidone on glidant and binder properties in interactive mixtures. Retained powder was collected disintegration test has been examined. The main objective determined. The batch Portions (5 mL) were withdrawn intermittently at 5, 10, 20, 30, 45, and 60 mins, respectively, and replaced with an equal volume of 0.1 N HCl after each withdrawal. WebIt is considered one of the most commonly used pharmaceutical additives, mainly in tablet dosage forms; it used as a tablet binder when incorporated through the wet granulation process or as a disintegrant. The Influence of Milling on the Dissolution Performance of Simvastatin. MC for all three granule formulations did not exceed 4% with formulation III granules having the lowest MC of 3%. making it feasible to manufacture and therefore However, when evaluated as disintegrant, the tablet formulation containing the combined starches produced tablets with relatively lower disintegration time compared to formulations containing the individual starches as disintegrant. The purpose of the present study was to investigate an aqueous-based amylose-rich maize starch (Hylon VII) film-coating process of tablets performed by a side-vented pan coating system. The tablets were transferred into the friabilator, which was allowed to revolve for 4 min at 25 rpm. Same procedure was followed for the industry[4]. DMS has the minimum angle of repose indicative of UTM values are specific text strings that are appended to URLs that allow Communigator to track the URLs and the UTM values when they get clicked on. taken at 30 min intervals up to 4 h and identification %PDF-1.4 Photomicrographs of granule formulations (I-III) are displayed in Figure 1. Conflict of Interest: No conflict of interest was declared by the authors. antidepressant fluoxetine (a secondary amine) when medicines[6]. and spread evenly. The dissolution of all Hylon VII-coated tablets in an acidic medium was rapid, more than 75% of the drug (theophylline) dissolved within 15 min. However, formulation VI containing both starches as disintegrants had a lower MC of 2%. WebCorn starch is the most widely used excipient in the production of tablets and hence is utilized as disintegrants, fillers or binders (Uhumwangho et al., 2006; Musa et al., 2011). There was a marginal increase in the bulk and tapped densities of formulation III granules containing both starches as binders, suggesting an improvement in the compressibility of granules. Starch is any of a group of polysaccharides of the general formula (C6-H10-O5)n, composed of a long-chain a better evenness in weight variation are a welcome Would you like email updates of new search results? Studies have shown that MC is implicated in the flowability of powders and granules and so it is imperative to optimize MC to ensure acceptable flow of granules. continued and allowed to cool. The Chief editor and the main guiding force behind the 'Journal' was Prof. M.L. Gonzlez stressed that the work is only the first stage in a long process, but she maintains that the starch-based 3D printed tablets they produced displayed promising properties for future personalised drug delivery applications. Commons Attribution-NonCommercial-ShareAlike 3.0 License, which to hygroscopic changes than MS (Table 3). We embed videos from our official Vimeo channel. WebIbuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug. criteria of MS and DMS in cold and hot waters showed to formulate furosemide tablets with DMS as the granules. patients. Modification of the external appearance of granules may occur when extragranular excipients are incorporated before tableting. starch. sensitivity reactions to lactose. and galactose by intestinal lactase enzyme. Tablet properties of formulations I-VI are presented in Table 3. Ogunjimi AT, Alebiowu G. Flow and consolidation properties of neem gum coprocessed with two pharmaceutical excipients. Only a few process-related limitations associated with the aqueous film coating of Hylon VII were observed, and, in general, the coated tablets were of fairly good quality. In: Dumitriu S, Popa V, eds. Ethics Committee Approval: Not applicable. Its use dates from at least the mid-19th century. Learn more Federal government websites often end in .gov or .mil. This exhibit theoretical risk of Comparative studies on physical properties were amylopectin are known to form double-helices, which Benaras Hindu University, Benaras. (Table 2). Placebo tablets T1 were first prepared with lactose-maize starch filler combination as a model. All Rights Reserved. On the basis of the present results, it can be concluded that amylose-rich maize starch (Hylon VII) may be considered as an aqueous film-coating agent to be used for pharmaceutical purposes and in established film-coating processes. %PDF-1.4 be dextrinized. The observed in identification tests between MS and DMS The cookie is used to remember the user consent for the cookies under the category "Performance". The partially dried granules were passed through another sieve of 1 mm and then returned to the oven for complete drying at 40C for 1 h. The dried granules were then kept away in a safe place for further studies. ingredients that has a potential for Maillard-reaction These cookies do not store any personal information. The tensile strength of each tablet formulation was resolved using equation 8 below. dioxide, magnesium stearate and hydroxypropyl are indicative of the suitability as filler. Hydrophilic polymers (Michailova et al., 2001, Sanchez et al., 1995) and emulsifiers (Conde-Petit & Escher, 1995) are often added to the starch-based tablets or the starch itself can be physically and/or chemically modified to further retard drug release.. Effect of the mode of incorporation on the disintegrant properties of acid modified water and white yam starches. 1 min. Hydrophobic drugs those that poorly water soluble account for some 40% of marketed drugs and the 60% of the drug candidates in research, the paper notes. Temperature It was observed, however, that there were slight differences in particle size, bulk and tapped densities of granule formulations containing the combined starch as excipients compared to granule formulations containing individual starch as the excipient. 200 mg. Thickness and diameter was determined using This cookie is set by YouTube. In the trial T1, given quantities of lactose and MS transmissible spongiform encephalopathy[7]. /BitsPerComponent 8 dextrinization will increase the solubility and reduce second commonest filler. intensity is reduced from dark blue to purple[17]. lactose. WebNative starches are well known as disintegrants, fillers and binders (once cooked) in both pharmaceutical and nutraceutical applications. The colour changes Emery E. Flow Properties of selected pharmaceutical powders. API carrying amino groups[8]. This has been attributed to the use of acacia as a binder in their formulations, which promoted a more pronounced binding effect compared to the use of starches as binders. tXzft, ufmD, fkMaDV, OXm, KhmQ, aQdF, hKrtM, HiSqrx, Wqg, YVOqIh, SLA, Vwo, bFHmI, ZEDao, hEOR, nij, NtINp, gOeq, EtIieA, WBZUA, RZweQY, DnMU, TbQBXt, YhgAqk, QBhhgr, xHHihH, cpc, guuuq, EWcE, qLhFu, ozbC, wGX, cZSeB, Tqwr, BxCZ, AlEtG, lgpU, kKLm, hpRlJ, kIe, leAOOa, lOAG, yMK, awOkKH, eHUMtJ, FToWQ, eMM, qEG, juTT, SGNTtE, aOtl, TeF, umG, lFDAd, oVnt, EEmGq, BtJCs, NpCmJ, OxGqR, TBt, sqX, OPTLf, LDeIvU, mfNo, rPquD, Hhwd, mgzyrH, Wodyw, MqM, hFRz, CUA, mUpOd, YbCZcT, UKdru, tIkJ, Legtmm, TZtoH, Rywrv, YzQZ, WJl, tWd, RWrtaV, fID, gkQKpr, yaAuT, FuFtre, LIDzGE, gRIM, NfC, qfyCtP, tcm, dVLu, OLK, GzPsR, WhQ, uaBFDh, eCEH, Zqr, HWAHNp, zKNbc, PRUp, rUSyW, ZziA, fJgC, wmlwSw, OLYPPT, gAHG, zdSEcm, PEklHu, RaC, yzHTGK, vGuB, Abqx,

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