Evaluation of Microbial Stability of Formulations : Pharmaguideline

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Evaluation of Microbial Stability of Formulations

As a result of spoilage, pharmaceuticals and excipients lose quality and become unusable, resulting in a loss of quality and financial damage.


As a result of spoilage, pharmaceuticals and excipients lose quality and become unusable, resulting in a loss of quality and financial damage. It may be necessary to discard the entire batch. There could be significant financial losses for the company. Additionally, a lawsuit from a consumer may cause the company significant financial losses. This may lead to additional financial losses for the manufacturer as damaged products may harm their reputation. The deterioration of microorganisms can pose a health risk to consumers by causing toxin exposure, illness, or death. The development of microorganisms can lead to the production of toxic metabolites that pose health risks. The degradation of medications by bacteria can reduce their effectiveness.

There is total three types of spoilage in pharmaceutical products that include -
  • Physiochemical spoilage
  • Biological spoilage
  • Chemical spoilage
Pharmaceutical deterioration may result in the formation of an undesired and harmful compound with negative biological consequences. Toxins, pyrogens, and other toxic metabolites can be produced by certain microorganisms. There is a possibility that these biomolecules are already in the product. Despite the lack of microbial contamination, spoilage may occur.

There are several elements that influence microbial deterioration. It is possible to reduce spoilage by changing some variables, but spoiling can also be increased by changing others. In addition to nutrition, the environment, and microorganism type all play a role in these factors. To reduce the impact of spoiling, several aspects must be investigated.

Antimicrobial agents are compounds that may either kill or hinder the development of microorganisms. These antimicrobial compounds are used in formulation to reduce the number of contaminated microorganisms. Preservatives are the name given to these antibacterial compounds. In general, these preservatives can prevent or kill low quantities of contamination. The use of preservatives is not necessary for formulations that do not pose a risk of contamination. Preservatives may not be required in formulations containing significant levels of acid, alkali, sugar, and so on. Antibiotic and other antimicrobial chemical formulations may not require a preservative. The following features should be found in a good preservative. It must be a broad-spectrum antimicrobial agent, meaning it must be effective against a wide range of microbes. However, the majority of active preservatives are useless against some bacteria.

Evaluation of Microbial Stability of Formulation

The efficiency of a formulation's preservative determines its microbial stability. Although chemical and biological assays can ensure the efficiency of a preservative, it may lose its action owing to the presence of other substances in the formulation. Some formulations don't need preservatives since they self-preserve. Some formulations do not require preservatives because they contain antibacterial agents such as antibiotics. Some formulations may have a high sugar content, a high salt content, and may operate as a self-preservative. As a result, the formulation's capacity to defend itself from microbial growth must be determined in order to assess the formulation's microbiological stability. It is accomplished by the use of a preservative effectiveness test.

The basic idea behind this test is to inoculate items with various types of defined microorganisms in a precise amount. At regular intervals, a little amount of infected product is withdrawn. The viable count of this removed sample is then calculated. This form of testing is recommended by the American Pharmacopoeia, the European Pharmacopoeia, and other organizations. The test organism concentration should be 105-106 cells per mL or gramme. Total microbiological count is done in 0 hours, 6 hours, 24 hours, and 48 hours. Seven days, fourteen days, and twenty-eight days. Even after 28 days, the British Pharmacopoeia advises testing.

For this aim, many bacterial species are utilized. They are S. aureus, Pseudomonas aeruginosa, and E.coli.

If necessary, this test allows for the addition of certain microorganisms. Following sample removal and before to viable count, the sample is combined with agents that can deactivate preservative since the presence of even a trace amount of preservative can interfere with microbial viable count. Performance requirements are classified into two groups. Criteria A is preferred and encouraged, although Criteria B is acceptable in justified instances.
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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