Page 51 - MNU-PM502- Pharmaeutical Microbiology Theoritical Book

Pharm D- Clinical Pharmacy Program Third Level Pharmaceutical Microbiology& Antimicrobials (PM 502)

Microbial contamination and preservation of pharmaceutical product

• Many medicines contain a wide variety of ingredients, included to create

formulations which are efficacious, stable and acceptable to patients

Spoilage: is chemical and physicochemical degradation of pharmaceutical
products rendering it unsuitable for use.

What is the problem of spoilage?

Such spoilage usually results in major financial problems for the
manufacturer, either through direct loss of the faulty product or,

possibly, expensive litigation with aggrieved users of the medicine

Types of spoilage

Chemical

• Deterioration of chemical nature of drugs and excipients
• Potency of the drug may decrease or become inactive

Physicochemical

• Viable growth in the form of Floating layers, turbidity, Gas production, Odour
formation, Taste change, Colouration / Decolouration

Biological

➢Pharmaceutical products are susceptible to contamination by a variety of
microorganisms.

➢Endotoxins can induce acute and often fatal febrile shock if they enter the
bloodstream via contaminated infusion fluids, even in nanogram quantities

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