EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

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 ISSN 2394-3211

Impact Factor: 7.065

 ICV - 79.57

Abstract

QBD APPROACH IN FORMULATION AND EVALUATION OF SUMATRIPTAN SUCCINATE BILAYER BUCCAL TABLETS

Dr. Sadhana R. Shahi, Swati V. Deore* and Priyanka D. Dabir

ABSTRACT

The present investigation was focused on application of QbD approach to see the effect of formulation variables on buccal mucoadhesive tablets containing anti‐depressant drug, Sumatriptan succinate to circumvent the first pass effect. Risk assessment of critical material and process parameters are linked to critical quality attributes (CQAs) of the product with respect to obtain target quality product profile (TQPP). The effects of critical parameters (concentration of HPMC K100LV, Carbopol 974P) were investigated by executing design of experimentation (DoE) using 32 factorial designs. Drug release, mucoadhesive strength and mucoadhesion time were considered critical quality attributes (CQAs). Sumatriptan succinate buccal mucoadhesive tablets were prepared by direct compression method and were evaluated as per pharmacopoeia procedure. Multiple regression analysis and ANOVA were employed to identify and to estimate the effect of important parameters and establish their relationship with CQAs and to obtain design space for optimization purpose. The best in-vitro drug release profile, mucoadhesive strength, Mucoadhesion time and desired product quality was achieved with the formulation prepared in theregion of design space.3D response graph and Overlay plot were successfully implemented to interpret effects and selection of significant parameters on CQAs. Formulation parameters which affect the Sumatriptan succinate buccal mucoadhesive tablets can be successfully optimized.

Keywords: Sumatriptan succinate, Buccal tablets, HPMC K100LV, Carbopol 974P, Mucoadhesive.


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Google Scholar Indian Science Publications InfoBase Index (In Process) SOCOLAR, China Research Bible, Fuchu, Tokyo. JAPAN International Society for Research activity (ISRA) Scientific Indexing Services (SIS) Polish Scholarly Bibliography Global Impact Factor (GIF) (Under Process) Universal Impact Factor International Scientific Indexing (ISI), UAE Index Copernicus CAS (A Division of American Chemical Society) USA (Under Process) Directory of Open Access Journal (DOAJ, Sweden, in process) UDLedge Science Citation Index CiteFactor Directory Of Research Journal Indexing (DRJI) Indian citation Index (ICI) Journal Index (JI, Under Process) Directory of abstract indexing for Journals (DAIJ) Open Access Journals (Under Process) Impact Factor Services For International Journals (IFSIJ) Cosmos Impact Factor Jour Informatics (Under Process) Eurasian Scientific Journal Index (ESJI) International Innovative Journal Impact Factor (IIJIF) Science Library Index, Dubai, United Arab Emirates Pubmed Database [NLM ID: 101669306] (Under Process) IP Indexing (IP Value 2.40) Web of Science Group (Under Process) Directory of Research Journals Indexing Scholar Article Journal Index (SAJI) International Scientific Indexing ( ISI ) Scope Database Academia