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Granulation and Production Approaches of Orally Disintegrating Tablets
Published in Dilip M. Parikh, Handbook of Pharmaceutical Granulation Technology, 2021
Tansel Comoglu, Fatemeh Bahadori
Superdisintegrant excipients determine the disintegration and consequently the dissolution time of ODT. Other water-soluble excipients and effervescent agents used in ODT formulation help the process of disintegration, while fibrous water-insoluble structures such as crospovidone provide mechanical strength. Crospovidone, a crosslinked PVP derivative, acts through various mechanisms such as swelling and wicking releasing the payload drug. Disintegration is achieved by the strain recovery of crospovidone. This material is also suitable for the production of ODT using the wet granulation compaction method. During compaction, the polymer faces some deformations. Upon contact with saliva, crospovidone absorbs water by capillary forces which provide reassembly of polymer structure. This is associated with releasing a certain amount of energy that is able to break the tablet and start the dissolution process. The swelling of crospovidone does not cause gelling which is the desired property in the production of ODT, in which gelation causes the delay of disintegration time. Noteworthy, the disintegration time is proportional to the crospovidone size. The larger the size, the faster the disintegration is [39].
Versatile Nature of Poly(Vinylpyrrolidone) in Clinical Medicine
Published in P. Mereena Luke, K. R. Dhanya, Didier Rouxel, Nandakumar Kalarikkal, Sabu Thomas, Advanced Studies in Experimental and Clinical Medicine, 2021
K. R. Dhanya, P. Mereena Luke, Sabu Thomas, Didier Rouxel, Nandakumar Kalarikkal
Most significant role of precipitation agents is its use as drug excipient. The unfavorable consequence of most of the drugs is its low solubility in water, reduced bioavailability, etc. When on adding PVP composites with these drugs, the rate of dissolution and drug solubility is remarkably increases. If we are considering the insoluble drugs, PVP is widely applicable as a precipitating agent. The remarkable property of this polymer is that, used for extension of agonist and the drug release method in capsule shell as well as membranes and disintegrating agents in solid drugs. PVP coated Membrane with the capsule shell in a dry condition is not easily release. Insoluble Polyvinylpyrrolidone is known as Crospovidone and prepared by the physical crosslinking reaction of PVP with a monomer containing bi-functional unit in presence of alkali at 100°C. This is also used as a perfect disintegrant tablet formulation and forms complexes with other substrates. In ophthalmic solutions, role of PVP termed as a demulcent or moisturizer and on blended with polyethylene glycol (PEG) 400 and dextran 70, it is useful for slight irritations, eye dryness, wind, and sun [172]. Discussing the nature of PVP, it is physiologically inert but hard, transparent, oxygen-permeable material and on crosslinking reactions, PVP forms various crosslinked networks [173]. This polymer is comparatively stable at normal conditions and can form complexes with various other compounds such as dyes, organic substartes, etc. Complexes of PVP can remove by filtration process.
Atazanavir
Published in M. Lindsay Grayson, Sara E. Cosgrove, Suzanne M. Crowe, M. Lindsay Grayson, William Hope, James S. McCarthy, John Mills, Johan W. Mouton, David L. Paterson, Kucers’ The Use of Antibiotics, 2017
The drug is formulated as an oral capsule, with strengths equivalent to 100, 150, 200, and 300 mg of atazanavir (as the sulfate). The inactive ingredients of the capsule include crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells consist of gelatin, FD&C blue 2, titanium oxide, and black, red, and yellow iron oxide.
Scalable flibanserin nanocrystal-based novel sublingual platform for female hypoactive sexual desire disorder: engineering, optimization adopting the desirability function approach and in vivo pharmacokinetic study
Published in Drug Delivery, 2021
Marianne J. Naguib, Amal I. A. Makhlouf
Disintegration time is crucial in the development of sublingual tablets. According to USP, the disintegration time of sublingual tablets should not exceed 2 min. Table 3 demonstrates the disintegration time of the prepared FLB-NCT. The disintegration time ranged from 36 ± 4 to 180 ± 9 s, and the formulae came in the following order FLB-NCT1 > FLB-NCT2 > FLB-NCT3 > FLB-NCT4. The disintegration time of the prepared tablets increased with the decrease in Pharmaburst® content in the formula. This is most probably attributed to the presence of crospovidone as a component of Pharmaburst®. Previous research reported a disintegration time of less than 40 s for sublingual tablets containing crospovidone (Khinchi et al., 2011). Accordingly, FLB-NCT4 was chosen for further investigations.
Quality-by-design approach for the development of telmisartan potassium tablets
Published in Drug Development and Industrial Pharmacy, 2018
Ga-Hui Oh, Jin-Hyun Park, Hye-Won Shin, Joo-Eun Kim, Young-Joon Park
TP was provided by Hwail Pharmaceutical Co., Ltd. (Seoul, Korea). Magnesium oxide (MgO) was purchased from Tomita Pharmaceutical Co., Ltd (Tokushima, Japan). Potassium chloride was purchased from Samchun Chemical Co., Ltd. (Pyeongtaek-si, Korea). D-mannitol was purchased from Merck & Co., Inc. (Kenilworth, NJ). Microcrystalline cellulose and croscarmellose sodium were purchased from JRS Pharma Co., Ltd. (Patterson, NY). Crospovidone was purchased from BASF Pharma Co., Ltd., (Rotherstrasze, Berlin, Germany). Colloidal silicon dioxide was purchased from Evonic Health Care Co., Ltd., (Rellinghauser Strasze, Essen, Germany). Magnesium stearate was provided by Merck KGaA (Frankfurter StraBe, Darmstadt, Germany). All other chemicals were of reagent grade and obtained commercially.
Formulation strategy towards minimizing viscosity mediated negative food effect on disintegration and dissolution of immediate release tablets
Published in Drug Development and Industrial Pharmacy, 2018
This study is able to provide some evidence of the impact of viscosity on formulation and processing variables in tablets. Therefore, evaluation of tablets under simulated fed state – with an emphasis on food viscosity – in addition to the simulated fasted state is suggested. Disintegrants that act without gelling or which can counteract the effect of gelling are recommended when tablet formulations, with an objective of reducing negative impact of food induced viscosity on dissolution and bioavailability of API, are being optimized. Based on the current study, crospovidone appeared to be an automatic choice due to low MDT values, but being relatively insensitive to changes in compressional force, croscarmellose sodium may also be considered. Therefore, formulators may consider the use of CPD and CCS while formulating tablets, to be taken with food, in order to get optimum results. Further optimization with respect to the dose and nature of API used is also suggested. Similar work with other diluents and combinations of disintegrants should be performed in the pursuit of improved formulation strategies.