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 ) , 

 ISSN 2394-3211

Impact Factor: 6.222

 ICV - 79.57

Abstract

BIOEQUIVALENCE MODULATION WITH MODIFIED STARCH IN ORODISPERSIBLE TABLETS IN COMPARISON TO MARKETED CONVENTIONAL TABLETS OF ROSUVASTATIN CALCIUM

*Tapas Kumar Pal, Debaditya Saha and S. Maity

ABSTRACT

Poor solubility and permeability of slightly soluble drug, Rosuvastatin calcium, often expose a problem of low bioavailability (absolute bioavailability 20%) as its dissolution and permeation are the rate limiting factors, so it becomes a challenge to improve dissolution and permeability of Rosuvastatin calcium oral conventional solid dosage forms. The dissolution profile and bioequivalence modulation of oral solid dosage form depend mostly on its formulation excipients and method of manufacture. Considering that in vitro dissolution studies can simulate in vivo bioequivalence of the therapeutically equivalent branded and generic versions of the same API, the present study had been targeted to explore bioequivalence modulation and justify interchangeability of marketed oral drug products by comparing the multipoint in vitro dissolution profile, per cent cumulative drug release (%CDR), dissolution efficiency (%DE) and the similarity factor (f2) among different commercially marketed formulations of Rosuvastatin Calcium 5 mg tablets along with the Orodispersible tablets of Rosuvastatin Calcium (5 mg) formulated with modified Starch by solid dispersion technique. In the present study modified Starch (Starch-5-phosphate) was prepared in the laboratory by reaction of starch with di-sodium hydrogen orthophosphate, anhydrous at elevated temperatures (>1300 C) and the product was found to be white, crystalline, non-hygroscopic powder, insoluble in water and aqueous fluids in acidic and alkaline pHs as well. It has no pasting or gelling property when heated at 1000 C in water for 30 min. As starch phosphate exhibited good swelling (> 400%) in water, it was evaluated as disintegrant in tablet formulations. Orodispersible Tablets of Rosuvastatin Calcium 5 mg were prepared by direct compression method using starch phosphate with PEG as solid dispersion in the ratio of Rosuvastatin calcium : PEG 6000 : Starch-5-phosphate in the ratio of 1:1:1 (F1cc), 1:2:5 (F4cc) and 1:1:9 (F5cc) and were evaluated. The dissolution efficiency (%DE5) obtained in Orodispersible tablet formulations were found as 84.22% (F1cc), 88.11% (F4CC) & 89.19% (F5cc) in comparison to 29.40% & 25.20% for CRESTOR & ROSUVAS (Branded commercial tablet formulations) justifying that Rosuvastatin solid dispersion with starch-5-phosphate as significantly better alternative than commercially marketed oral tablets of Rosuvastatin Calcium with faster dissolution and improved bioavailability. Furthermore, the results of the study revealed that ROZUCOR & ROSUVAS have been found bioequivalent and interchangeable with CRESTOR (Innovator Brand) having similarity factor (f2 value) > 50; whereas ROSUMAC & ZYROVA have not been found bioequivalent and interchangeable with CRESTOR (Innovator Brand) having similarity factor (f2 value) < 50. Incidentally, all the formulated Orodispersible tablets were found bioequivalent & interchangeable.

Keywords: Bioequivalence, Dissolution efficiency, Orodispersible, starch-5-phosphate, solid dispersion.


[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 Scholar Article Journal Index (SAJI) International Scientific Indexing ( ISI )