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In the development phase of all drugs, the active pharmaceutical ingredient (API) often dictates the type of dosage form that the final marketable product will be. It all comes down to how the API will remain stable in storage and of course, once it enters the body before it reaches its target release site. In order to ensure the stability of the final dosage form, formulation studies must be efficiently done.

Achieving a successful formulation study requires a systematic planning and design of the manufacturing process. To obtain such success, the following basic components must be considered:

  • Physicochemical attributes of the API
  • Compatibility of excipients
  • Manufacturing procedure
The major concern of formulation studies is really on the interaction of the API and its excipients as these are hard to predetermine. The output of such studies (physical/chemical/therapeutic interactions) will then help dictate the final recipe for a certain drug dosage form.

Moreover, it must also be noted that pharmaceutical formulation studies must be free from any untoward microbial or chemical contamination as these events may change both the physicochemical and therapeutic properties of the formulation. To ensure this, preservatives are added both to prolong shelf life and to maintain sterility for a specific period of time.

The formulation process may be divided into:
  • Pre-formulation
  • Formulation:
  • Process Development
Prior to the process development part, formulation studies involve understanding the biological API on the level of is amino acid sequence, biochemical and biophysical characteristics (pH), ionic strength, possible excipients, and even stability-indicating assays to check possible degradation pathways for the biologic under study.

Nowadays, the field of biologicals and biopharmaceuticals is growing rapidly so it is important to determine all potential issues in every stage of its development. Along with the rise of such drugs comes also the increase in complexity of formulating longer-acting formulations with larger injection volumes and longer injection durations. One of the major challenges faced by the biopharmaceutical industry is the stabilisation of the drug during processing. Main reason is that these substances are inherently unstable and prone to degradation, hence, a variety of excipients is required to stabilise aseptic/sterile biologicals during manufacturing processes.

On this note, formulation studies are critical as this is where the final excipients for drug stability, and of course efficiency, is determined. Finalizing the drug recipe at an early stage will also lessen operational costs as it can prevent drug product recalls and any unwanted adverse drug reactions once the drug is released in the market. Therefore, having the most suitable excipients combined with the selected API will dictate the success of developing a possible novel drug.