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)

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 , Scholar Article Journal Index (SAJI) , International Scientific Indexing ( ISI ) , Scope Database , Academia , 

 ISSN 2394-3211

Impact Factor: 7.065

 ICV - 79.57

Abstract

ACCELERATING THE DEVELOPMENT OF SOLUBILITY-ENHANCED SOLID DISPERSIONS: USE OF MILLISCALE AND MATHEMATICAL PREDICTION OF DRUG-POLYMER MISCIBILITY

Abigail Garcia-Radilla, Mariana Ortiz-Reynoso*, Edna T. Alcantara-Fierro and Jonnathan G. Santillán-Benítez and Fernando Hernández-Martínez

ABSTRACT

Introduction: Most solid oral drugs currently in a developmental phase, have low solubility in aqueous systems. This reduces their pharmacological efficacy because drug absorption is slowed down. Solid dispersions are an option to improve both dissolution rate and apparent solubility of poorly soluble drugs. Aim: This work shows the effect of different drug-polymer proportions and a plasticizer in ternary solid dispersions at a milligram scale, on the drug dissolution rate, and evaluates its correlation to the calculated Flory-Huggins theoretical model. Methods: We evaluated the drug-polymer miscibility using the melting point depression method by the Flory-Huggins theory and the dissolution rate of ketoconazole in ternary solid dispersions manufactured by melting granulation. Results: All ternary solid dispersions decreased the enthalpy of fusion of the drug, however, only those made with PVP/VA 64 and HPMCAS HF improved the solubility kinetics at pH: 1.2 and 6.8 respectively. The proportions with the best results were 1:2 for HPMCAS HF (p = 0.0023) and 2:1 for PVP/VA (p = 0.0053) (drug:polymer). The Flory-Huggins parameter yielded a correlation with PVP/VA 64 and HPMCAS HF, but not with Soluplus®, indicating that the theoretical model needs to be improved to reflect this last case. Conclusion: The studies carried out in the present work are useful, practical and simple to improving the dissolution of poorly soluble drugs (KTZ), reducing costs and mitigating risks associated with the development of solid dispersions manufactured by fusion techniques.

Keywords: Solid dispersion, Drug-polymer miscibility, Melting process, Dissolution.


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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