INTRODUCTION

Pharmaceuticals preparations are used in diverse of ways in diseases prevention, diagnosis and
treatment. There have been reports of drug-borne human infections worldwide as a result of the
use of contaminated pharmaceuticals which has been confirmed dangerous to the health of the
end users (Cooker, 2005). Microbial contamination of pharmaceutical preparations can also
result into change in their physical features which includes breaking of emulsions, thinning of
creams, fermentation of syrups, appearance of turbidity or deposit, and changes in odor and color
(Shaikh, 1998). Recently, pharmaceuticals manufacturers have improved the quality of nonsterile
pharmaceuticals such that today such products contain only minimal level of microbial
contaminant (Hugo, 1998). the nature of the ingredients (whether natural or synthetic), the
quality of the vehicle and the care and attitude of personnel involved in their handling generally
influence the Occurrence of bioburden in non-sterile preparations (Parker, 2000). The presence
of microbial contamination has been properly recorded and documented, the contaminants range
from true pathogens such as Clostridium tetani, to opportunistic pathogens such as Pseudomonas
aeruginosa (Aulton, 2002). The main concern is when such microbial contaminants exceed
acceptable limits (102 cfu/mL) (USP, 2003). Antimicrobial agent may be added in a formulation
to reduce the risk of spoilage and preferably to destroy low levels of contaminants introduced
during storage or reuse of multi-dose preparations (4). Solid dosage forms (capsules or tablets)
are prone to microbial spoilage or degradation. The recent alarming constrains as a result of from
microbial contamination of solid dosage forms is the non-present of observable signs of spoilage.
Thus, it is needful to know the microbial profile of all drugs and medicines, whether they are
sterile or nonsterile (Parker, 2000). As a result of increased number of immunocompromised
patients, high attention is given to the identification and quantitation of microorganisms in oral
pharmaceuticals. Therefore, a systematic approach is needed by manufacturers of non-sterile
oral pharmaceuticals to assess the importance of microbial isolates rather than primary pathogens
and/or those in product monographs taking into note the amount of organisms present, the type
of dosage form, and the potential hazard to the end user. The objective of this discussion is to dig
deep into how microorganism involve in spoilage of pharmaceuticals can be isolated, identified
and estimated.
COLLECTION OF PHARMACEUTICAL TEST SAMPLE

Pharmaceutical preparations are randomly selected. The samples selected were either obtained
from the pharmaceutical company before is been released out for sales, or purchased sporadically
from various retail pharmacies. Tablets, capsules, and syrups constitute a large proportion of the
medicines on the market, are dispensed in all health facilities, and are prone to microbial
contamination when stored under improper conditions (Mugoyela and Mwambete, 2010). The
selected drug samples are representative of pharmaceutical products to be tested or examined for
the presence of spoilage microorganism which would definitely render the products useless
(Aboulwafa, 2013). Each of the products to be tested for is randomly selected from the shelves
and is sterilely dispensed into well labeled sampling bottle. Label information should contain
batch number, expiry date, manufacturing date, directions for use, and ingredient composition.
According to the United States Pharmacopeia the procedure for sampling preparation is a
function of the physical features of the product to be tested. The outside surfaces of all containers
were swabbed with 70% v/v ethanol before opening. Not less than 1 g (solids or semisolids) or 1
ml (liquids) samples were tested for each product and 1:10 sample dilutions of the
pharmaceutical products in each of sterile Trypticase Soy Broth (TSB) and Sabouraud Dextrose
Broth (SDB) were prepared. All dispersions were allowed to settle for five minutes to dislodge
available microbial cells.

ISOLATION:
Parker MS. Microbiological contamination and preservation of pharmaceutical preparations. In: Aulton
ME, editor. Pharmaceutics: The Science of Dosage from Design. Hong Kong, China: Churchill Livingstone;
2000

. Hugo WB, Russell AD. Pharmaceutical Microbiology. 6th ed. Oxford, UK: Blackwell Scientific
Publications; 1998

United States Pharmacopeia (USP-62) Microbiological examination of nonsterile products: Tests for
specified microorganisms. Pharm Forum. 2003;29(5):1722–1733

Aulton ME. Pharmaceutics: The Science of Dosage Form Design. 2nd ed. London, UK: Churchill
Livingstone; 2002

Coker M. An assessment of microbial contamination during drug manufacturing in

Ibadan,Nigeria, Eur J Scientific Res 2005; 7: 19-23.

2. Shaikh D, Jamshed TA, Shaikh R. Microbial contamination of pharmaceutical

preparations, Pak J Pharm Sci 1988; 1: 61-6.

3. Parker MS. Microbiological contamination and preservation of pharmaceutical

preparations. In: Pharmaceutics: The science of dosage from design. 2nd edn. China,
Churchill Livingstone, 2000; p 220