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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



Mostafa Essam Eissa* and Ahmed Mohamed Mahmoud


Bioburden determination and detection in the drug products is a crucial attribute in pharmaceutical manufacturing industry that affects both the patients and the reputation of business holders. Establishment and verification of the sensitivity for bioburden detection and enumeration in the dosage forms is critical in minimizing the potential hazard of delivering unsafe products with masked contamination to the market. In the present study, selected group of non-sterile dosage forms – including drugs with known antimicrobial properties - were tested for the ability to recover low level inoculums of pharmacopeial standard strains after applying specific neutralization and processing steps. The neutralization techniques included dilution, filtration, chemical neutralizers or combination of two or more of them together in a single procedure. Preliminary test was conducted to ensure non toxicity of the neutralization media or processes. The average combined microbial recovery of Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa, Candida albicans (20–25°C), C. albicans (30–35°C) and Aspergillus niger (20–25°C) and A. niger (30–35°C) from all tested pharmaceutical dosage forms was 0.89±0.36, 0.85±0.27, 0.94±0.47, 0.85±0.28, 0.80±0.35, 0.95±0.40 and 0.85±0.32 respectively. The tested products passed the criteria of microbial enumeration and detection of specified microorganisms, with exception of one topical antimicrobial cream with fungi, oral Azithromycin capsule with bacteria, Sodium Risedronate tablet with Pseudomonas aeruginosa (in one neutralization trial without chemical neutralizer) and oral Nifuroxazide capsule with Staphylococcus aureus. Interestingly, microbial recovery of B. subtilis, C. albicans and A. niger from tested products were significantly correlated with each other using Pearson correlation matrix.

Keywords: Bioburden determination and detection, non-sterile dosage forms, standard strains, neutralization techniques, correlation.

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  • New Issue Published

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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