| Kamat Pharmatech designs formulations and manufacturing processes that are consistent with the target product profile. Our expertise lies in the development of complex and unique injectable products - for vials, pre-filled syringes, ampules, and blow-fill-seal formats.
The first step in the product development is information gathering from the client about the potential drug candidate and arriving at exact definition of Target Product Profile. With this as a goal, we design formulation development such that the candidate drug is formulated to deliver the right dose via intended route of administration. The drug product itself must be stable, safe, acceptable to the patient, as well as amenable to be produced efficiently and economically.
Resulting formulation dosage form can be a simple solution ‐ an aqueous or non-aqueous or a more complex form such suspension, emulsion, or nano-suspension. In increasing cases, it can be even sustained release form such as microspheres. Formulation optimization is an iterative process and evolves as the product moves from the discovery to clinical to commercial stages. Inherent in the abovementioned decisions is the obligatory concern for product safety, effectiveness, stability, and reliability.
We at KAMAT understand and follow the necessary tasks involved in developing such products and have to our credit successful development case studies of every one of these.
Our formulation development capabilities include the following:
- Lyophilized vials/bulk trays
- Lyophilized dual chamber syringe
- Emulsions, liposomes, micro-, nano-suspsensions
- Blow-fill-seal technology
- Ampules and pre-filled syringes
- Potent, oncology injectable products
- Ophthalmic emulsion and ophthalmic suspension products
|