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Preservation of Pharmaceutical Products using Antimicrobial Agents

Pharmaceutical products are substances or mixtures intended for use in humans for diagnosing, treating, or preventing disease.
Pharmaceutical products are substances or mixtures intended for use in humans for diagnosing, treating, or preventing disease, altering or modifying bodily functions, or preventing abnormal physical states. Known as microbial spoilage, this occurs when these pharmaceutical products deteriorate as a result of contamination by microbes. Due to this, products must be preserved during storage and multidose use in order to reduce or eliminate spoilage caused by microbial contamination.

Acyclovir, amantadine, flumadine (essential medicines) are examples of prescription drugs in the pharmaceutical industry, while biological products include vaccines, antibodies, blood, therapeutic proteins, tissues, and many more. Pharmaceutical products include needles, syringes, gloves, aspirin and paracetamol, which are OTC drugs. The products can contain microbes like E. coli, Clostridium botulinum, Clostridium perfringens, Pseudomonas aeruginosa and Salmonella caveman.

As exceptions to a categorization such as this, antimicrobial preservatives help enhance antimicrobial stability and thus contribute to antimicrobial effectiveness. Consequently, the use of preservatives in pharmaceutical products containing antimicrobial agents is crucial. A good preservative should have the following properties:
  • Toxic or irritating effects should not occur at the specified concentration.
  • Microorganisms should not be able to grow under them.
  • Solubility in water is crucial so that the required concentration can be obtained.
  • Their heat stability should extend their storage capabilities.
  • Their chemical compatibility should extend across all formulations.
  • Containers and closures of the products should not adversely affect them.
  • The products should be inexpensive.
The protection provided by preservatives against viral contamination is limited. Microbes and fungicides can affect a wide variety of cellular targets, including their cell walls, cytoplasm, and membranes. The target doesn't always remain the same for every preservative class; it changes with the concentration of preservatives. The preservatives should consist of:
  • Antimicrobial activity ranging from low inclusion levels to a wide spectrum.
  • Ability to remain active during manufacture, storage, and usage.
  • The quality of the product, the packaging, and the delivery system is never compromised.
  • Effect on the product's tolerance or safety.
Based on their mechanism of action, preservatives are classified as follows:

Antioxidants - As active pharmaceutical ingredients are sensitive to oxygen, antioxidants prevent them from oxidizing.

Antimicrobial agents -
Micro-organisms that cause degradation of pharmaceutical preparations such as gram-positive and gram-negative bacteria can be neutralized by antimicrobial agents. These are active in a low-inclusion level. Sorbate, Benzoate, and Sodium benzoate are examples.

Chelating agents - Chemical agents are those capable of forming complexes with pharmaceutical ingredients and preventing degradation of the pharmaceutical formulation. The following are examples: EDTA, polyphosphates, and citric acid.

Preservative systems protect products against the growth of microorganisms with these concepts. An antimicrobial agent's mode of action as a preservative:

Inhibition of cell wall synthesis, protein synthesis, and DNA and RNA synthesis is how antimicrobial agents work. Sorbates, propionates, nitrates and benzoates, for example. Microbial growth will be supported by emulsions, which contain water. Emulsifying agents can be affected by microorganisms, which produce an unpleasant odor, color changes, and gases. Emulsions also contain additional ingredients that serve as a growth medium for microbes. Oils such as arachis oil and liquid paraffin support species like Aspergillus and Penicillium, respectively.

Antimicrobial preservatives are used in non-sterile dosage forms to suppress microbiological growth or to prevent the introduction of microorganisms during the manufacturing process or afterward. The inclusion of antimicrobial preservatives in sterile articles packed in multiple-dose containers prevents microorganisms from growing that may have been introduced through repeated withdrawals of individual doses. Alcohol, formaldehyde, and iodine are among the preservatives used to kill bacteria. To minimize the chance of spoilage, an antimicrobial "preservative" is added to multidose containers when they are stored or used repeatedly. Antimicrobial agents with strong activity are often not selective in action and interact significantly with all of the formulation ingredients as well as with patients and microbes.
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, 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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