Abstract
A COMPARATIVE STUDY FOR THE STERILIZATION OF MEDROXY PROGESTERONE ACETATE FOR PARENTRAL PRODUCT

Prof. Dr. Mahmoud M. Ghorab and *Dr. Tarek S. Makram

ABSTRACT

The sterility of parenteral product is an interesting subject to achieve stable formulae. The majority of solid active pharmaceutical ingredients (APIs) cannot be sterilized terminally since all sterilization techniques affect the quality of the product. The Aim of this study was to approach the best sterilization method for MPA solid micronized powders. Method sterilization of MPA powder has been done by three different techniques, namely, by autoclaving gamma irradiation and ethylene oxide. Studying the microbial, physical and chemical stability, the culture media Fluid Thioglycollate Medium ( FTM) and Tryptone Soya Broth (TSB) covered the intended data required for detecting, the microbial free state and the validity of either of stabilization techniques. Chemical and physical stability studied by HPLC method, X-ray diffraction and IR spectrum and loser diffraction particle size analysis were done. Result The most suitable technique was gamma irradiation using the required dose to the maximum of 25 KGys and autoclaving with conservation from the exposure to the most steam that could be expected to deform the crystallinity of the hydrophobic powder. Conclusion sterilization by ethylene oxide was the worst technique due to particle growth, according to a long duration time under RH = 60 and the most serious drawback was the fact of remaining toxic residues from ethylene oxide.

Keywords: Medroxy progesterone acetate (MPA), sterilization, micronized powder Parentral products.


[Full Text Article]   [Download Certificate]

Login





Forgot Password  |  Register

Indexing

Best Paper Awards

European Journal of Biomedical and Pharmaceutical Sciences (EJBPS) will give best paper award in every issue in the form of money along with certificate to promote research activity of scholar.

Best Article of current issue :

Dr. Dhrubo Jyoti Sen

Download Article : Click here

News & Updation

  • EJBPS: MAY ISSUE PUBLISHED

    MAY 2024 Issue has been successfully launched on 1 MAY 2024.

  • EJBPS New Impact Factor

    EJBPS Impact Factor has been Increased to 7.482 for Year 2024.

  • Index Copernicus Value

    EJBPS Received Index Copernicus Value 77.3, due to High Quality Publication in EJBPS at International Level

  • Journal web site support Internet Explorer, Google Chrome, Mozilla Firefox, Opera, Saffari for easy download of article without any trouble.

    .

  • Article Invited for Publication

    Dear Researcher, Article Invited for Publication  in EJBPS coming Issue.

     

UG/PG/Ph.D Research Publication

Research Scholar of UG/PG/Ph.D can Submit their Research Article/Review Article/Case Study/Short Communication for Publication in EJBPS

Downloads

Copyright From

Covering Letter

                        Author Instruction 
 

PLAGERLUM REPORT