EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

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)

European Journal of Pharmaceutical and Medical Research (EJPMR) has indexed with various reputed international bodies like : 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 , 

 ISSN 2394-3211

Impact Factor: 6.222

 ICV - 79.57

Abstract

QUALITY BY DESIGN APPROACH FOR DEVELOPMENT OF AZITHROMYCIN ORAL RECONSTITUTABLE SUSPENSION AND ITS COMPARISON WITH MARKETED PRODUCT

Devika Sonawane*, Dr. Pravin Chaudhari, Vikas Thorat and Shrikant Dhavale

ABSTRACT

The aim of this work was to develop stable suspension containing Azithromycin was suitable for large scale manufacturing. The product developed by QbD was found comparable with marketed product. The present investigation concerns with the evaluation of the effect of formulation variables on viscosity and phase separation volume in developing stable reconstitution suspension containing azithromycin by applying Quality by Design. The quality by design (QbD) approach was applied for optimizing the formulation of Azithromycin dry powder for oral suspension using Design-Expert Software (version 10.0 state ease, USA).A Central Composite Design (CCD) was employed in formulating the suspension containing Xanthan Gum (XG) and Hydroxy Propyl Cellulose (HPC). To optimize this formulation a Quality Target Product Profile (QTTP) was established in which Critical Quality Attributes (CQAs) such as viscosity and phase separation volume quantified. As Critical Process Parameters (CPP) that was evaluated for their effect on the CQAs the percentage of XG and the percentage of HPC were chosen.CCD was used to evaluate the effects of the CPPs on the CQAs of the final product. The main effect and interaction terms were evaluated by quadratic model to predict formulation with the desired viscosity and phase separation volume. The concentration of suspending agent and its quadratic term were found to be significantly effective for all the response variables.

Keywords: Azithromycin, Reconstitution suspension, Quality by Design, Design of Experiment.


[Full Text Article]

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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