Pre-formulation development services include physicochemical characterization of compounds, salt screen and polymorph screen. These measurements can add significant value to your development program as you would know the hurdles much earlier during the development cycle. Sai has a unique advantage as we can offer these services side by side to your development of lead molecules/candidates. Our chemistry, formulation and analytical scientists work together to find out the appropriate salt/polymorph for your molecule.
- Particle Size Analysis
- Moisture Sorption Studies
- Solubility Studies in various solvent systems / pH
- Choice of counter ion / DSC / TGA studies / Hydroscopicity studies
- Vehicle identification for PK studies
- Drug-Excipient Compatibility Studies
- Forced Degradation Studies (e.g. acid / base / photo / heat / oxidation)
- Stability Studies (temperature, relative humidity and photo stability)
NCE Formulation Services
We offer a broad range of services for NCE. Once again, the advantage for the client is parallel/overlapping formulation development steps at API and formulation development. This can save significant time in the development cycle. This also takes away the hassles in logistics and analytical method transfer, which is integrated within Sai. The formulation could be a simple API in capsule or a complex liposome based drug delivery system. Sai has expertise to develop the formulation and also to support it with analytics to compare the options and choose the best one for the client.
Our Bioavailability improvement solutions are specifically designed for each molecule after understanding the chemical nature, physicochemical properties, preferred route of
administration and safety profile. It is not mere improvement in the solubility but also choosing a system, which will ensure delivery to get better blood levels. Once again, the verification can be done by a quick PK study within Sai to get a proof-of-concept.
Send us a query if you are interested in any of the following:
- Formulations for Pre-clinical studies
- Prototype Formula Development/ FIH formulations
- Selection of Suitable Dosage Form (Oral, Parenteral, Topical, etc)
- Bioavailability improvement
- Analytical method development
- Analytical method validations
- Stability Studies (effect of temperature and relative humidity)
Generic Formulation Development Services
Sai’s experienced team can develop ANDA and generic products for Europe with a systematic approach. Awareness and commitment to agreed timeline, formulation development with QBD approach, knowledge about technology transfer are the highlights of our generic formulation development. We can handle solid as well as injectable dosage forms with a wide variety of technologies. We have a highly experienced Scientific team with combined experience of over 200 ANDAs.
Listed opposite are some of the technologies we handled and filed ANDAs for successfully.
- Tablets (coated, uncoated, sugar coated, film coated, ODT)
- Extended release and delayed release dosage forms
- Powders for suspensions and taste masked powders
- Enteric Coated Pellets
- Lyophilized powders
- Liquid filled parenteral products
- Clear liquids
Re-Formulation and Maintenance Services
Sai experienced formulation development expertise can be applied very effectively towards re-formulation of commercial products which no longer comply with the latest standards and advances in technologies.
Starting from the existing prototype, Sai will address the specific problem and develop new prototypes, which are then presented
to the customer for review and approval. Upon confirmation a tech-transfer will be facilitated to the existing production base of the product.
Formulation maintenance: Sai’s expertise is available for any upgrade of an analytical method, formulation conditions, QbD approach to improve the formulation performance in the plant.