Formulation Development

Formulation development is a major step in your drug development journey. The purpose of this step is to achieve a stable, bioavailable, patient-oriented, and manufacturable drug product. Other factors that need to be considered are the commercialization aspects, patentability, product innovation, and shelf-life. In other words, this step has a tremendous effect on your product success.

The formulation process is a complex challenge of combining the Active Pharmaceutical Ingredient (API) with the inactive ingredients (excipients). Multiple factors must be considered, such as route of administration (the way your drug will enter the body, i.e., oral, topical, intravenous), dosage form (the form in which your product will be marketed, i.e., tablet, syrup, cream), and API and excipients compatibility. Each excipient is chosen carefully in order to fulfill a defined purpose, such as enhanced API absorption, API preservation, API enhanced solubility, etc.

 

          Tip from our scientists

Planning your formulation development strategy in advance will help you reach a rapid, high-quality, cost-effective process. A powerful tool that is commonly used for formulation development strategy is Design by Experiment (DOE). Using DOE you can evaluate the interactions and effects of multiple parameters, predict the formulations and processes that can attribute to your product's pre-defined characteristics, and focus on them.

 

Services for you

  • Formulation development of innovative drugs- New Chemical Entity (NCE), cytotoxics, and biologicals.

  • Formulation development of different dosage forms:

    • Injectables including intradermal, subcutaneous, intravenous, intramuscular, etc.

    • Topical formulations such as creams, ointments, gel, lotions, etc. including drug formulations for dermal and transdermal patches.

    • Ophthalmic solutions (eye drops and eye lotions), suspensions, emulsions, ointments.

    • Oral solutions including syrups and suspensions.

    • Foams formulations.

  • Formulation development of sterile products.

  • Reformulation, repositioning, repurposing of generic drugs.

  • Improvement of solubility and bioavailability.

  • Taste masking.

  • Preparation of test articles for pre-clinical efficacy/toxicity studies.

  • Stability testing including storage in environmentally controlled chambers with 24/7 monitoring for all ICH climate conditions.

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