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RESEARCH JOURNAL OF PHARMACY AND TECHNOLOGY
Year : 2021, Volume : 14, Issue : 1
First page : ( 171) Last page : ( 178)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2021.00030.5

Combination effect of natural and synthetic polymers in extending the release of tolperisone HCl from its effervescent floating tablets

Saravanakumar K.1*, Rao Durga Srinivasa M.2, Chandrasekhar Kothapalli Bannoth3

1Professor and Head, Dept. of Pharmaceutics, Sree Vidyanikethan College of Pharmacy, A. Rangampet, Sree Sainath Nagar, Tirupati-517102, Chittoor (Dist.), Andhra Pradesh, India.

2Research Scholar, Dept. of Pharmaceutical Sciences, JNTU, Anantapur, Anantapur-515002, Andhra Pradesh, India

3Professor, Dept. of Chemistry and Director, Foreign Affairs and Alumni Matters, JNTU, Anantapur, Anantapur-515002, Andhra Pradesh, India

*Corresponding Author E-mail: kumarpharmacy156@gmail.com

Online published on 22 April, 2021.

Abstract

Aim and Objectives: The aim of the current study is to study the effect of combination of synthetic and natural polymers in extending the release of Tolperisone HCl (TH) from its effervescent Floating Tablets (FT), which can extend its release up to 12 h. Methods: The drug-excipient compatibility studies of TH and the polymers used in the study were carried by FTIR studies. THFT were prepared by direct compression method. All batches were evaluated for pre-compression, post-compression and in vitro buoyancy studies. Accelerated stability studies were performed for the optimized formulation THFT11 as per ICH guidelines. Results and Discussion: The drug-excipient compatibility studies reveal that TH and the polymers used for the study are compatible. Pre-and post-compression parameters were within the acceptable limits for all formulations. In vitro dissolution studies showed the formulation THFT11 (6.25% w/w sodium alginate and 18.75% w/w HPMC K100M) had extended the release of TH up to 12 h, with a floating lag time (FLT) of 58 ± 0.71 sec, total floating time (TFT) and matrix integrity (MI) maintained up to 12 h, hence it is selected as an optimized one. In vitro drug release kinetics of optimized THFT11; suggests the drug release follows zero order profile (r2=0.988), drug release is predominantly by diffusion and the release mechanism is by super case-II transport. DSC and FT-IR studies of TH and accelerated stability samples of F11 further confirmed the drug is in the same state as pure TH. Accelerated stability studies of optimized THFT11; indicates it passes the test for stability as per ICH guidelines. Conclusion: Finally, it was concluded that an optimized effervescent THFT was formulated and evaluated with the combination of synthetic and natural polymers.

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Keywords

Tolperisone HCl (TH), Floating tablets (FT), Hydroxy propyl methyl cellulose (HPMC), Sodium alginate (SA), Guar gum (GG), In vitro buoyancy studies.

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