FORMULATION AND EVALUATION OF BILAYER TABLET OF ANTI-INFLAMMATORY DRUG
Ajay Vitthal Bhutekar
, Dr. B.A. Mohite , Dr. K.R. Biyani
formulation and evaluation , Tablet , Anti-inflammatory
The present work is a formulation and evaluation of bi-layer tablet of Divalproex sodium, which is used in treatment of epilepsy, bipolar disorders and used in prophylaxis of migraine, was carried out. The formulation known as bi-layered tablet was developed with the aim to deliver the Divalproex sodium as immediate release and extent the drug release for 18 hours for the better and extended clinical effect. Compatibility studies by FTIR indicate that no significant interactions between excipients. Both layer were prepared by wet granulation and punched separately. Six formulations (IF1-IF6) of immediate release tablets were prepared by using sodium starch glycolate and croscarmellose sodium. Nine formulations (SF1-SF9) of sustained release were prepared by using HPMC K4M and HPMC K100M in different ration and combination. All formulations were evaluated for pre- compression and post-compression parameters. Bi-layered tablets were prepared by using selected best formulations of each layer. IF6 from immediate release layer as they showed 98.62 % drug release within 20 minutes. SF8 from sustained release layer as they showed 94.29 % drug release at 18 hours and also the release pattern was within the limit of sustained release tablet. Prepared bi-layered tablet were evaluated for post-compression paramaters. Drug excipient interaction was determined by FTIR. Short term stability studies of formulated bi-layered tablet were carried out at 400C / 75% RH for 3 months. The release kinetics of immediate release layer formulations (IF1-IF6) was found to following clearly first order kinetics as the values for ‘ r’ is (0.985 to 0.960) and values of ‘ n’ is more than 0.89 shown that Super case II transport. The release kinetics of sustained release layer (SF1-SF8) was found to following zero order kinetics as the value for ‘ r’ is (0.9918 to 0.9736)found to be high in comparison to first order (0.8986 to 0.7303) and Higuchi’s squareroot of time (0.9794 to 0.9074). ‘ n’ values in between 0.6634 to 0.6064 shown non-fickian release and drug. Stability studies at 40 0C / 75 % RH for 3 months for bi-layered tablet batches indicated that there are no significant loss in drug content, release profile and physical appearance. In summary, the release profiles bi-layered tablet formulations were quite promising for once a day formulation
"FORMULATION AND EVALUATION OF BILAYER TABLET OF ANTI-INFLAMMATORY DRUG", IJSDR - International Journal of Scientific Development and Research (www.IJSDR.org), ISSN:2455-2631, Vol.8, Issue 6, page no.1743 - 1762, June-2023, Available :https://ijsdr.org/papers/IJSDR2306235.pdf
Volume 8
Issue 6,
June-2023
Pages : 1743 - 1762
Paper Reg. ID: IJSDR_207454
Published Paper Id: IJSDR2306235
Downloads: 000347109
Research Area: Pharmacy
Country: Dist.Buldhana, Maharashtra , India
ISSN: 2455-2631 | IMPACT FACTOR: 9.15 Calculated By Google Scholar | ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 9.15 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator
Publisher: IJSDR(IJ Publication) Janvi Wave
