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.
Vehicle identification for PK studies
Drug-Excipient Compatibility Studies
Forced Degradation Studies (eg. acid/base/photo/heat/oxidation)
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.
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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. Listed below are some of the technologies we handled and filed ANDAs for successfully.
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.
A successful formulation development should always result in the manufacture of robust and stable products. SAI can support the clients to handle clinical supplies in various ways: Phase 1 and 2a cGMP supplies can be handled from our Pune site. For Phase 2b and 3 supplies, we have, within our reach, a number of CMOs having FDA/EU approvals for cGMP manufacturing. We can work with the clients to give them access to the CMO, ensure smooth tech transfer and manufacture of clinical supplies. The GMP sites have been audited by relevant regulatory bodies and can be audited by the client QA.
SAI’s formulation development facility is based in Pune. A lab space of 20,000 sq ft designed to house labs for preformulation, formulation dosage form design, Analytical laboratories and in a separate block, labs to handle development of formulations of highly potent compounds.
The formulation development laboratories are equipped for handling solid oral dosage forms (tablets and capsules) as well as parenteral dosage forms (liquid and lyophilized injections).
For the solid oral dosage design, we have equipment which allow the scientists to experiment with a wide variety of platforms such as direct compression, wet granulation, roller compaction, fluidized bed coating, bi-layered tablets, coating.
Similarly, the lab for injectable’s is equipped with laminar flow hoods, dry heat sterilizer, autoclave, membrane filtration sets for aseptic filtrations, lyophilzer.
For preparation of Liposomes, we have high-pressure homogenizer, probe sonicator, minimate system, Malvern Zetasizer.
The pre-formulation lab houses DSC, TGA and moisture sorption analyser ( all by TA instruments), Rigaku miniflex II XRD analyser, Malvern PSD analyser.
The analytical laboratories are spread over 9000 sq ft area. HPLCs (Waters), Dissolution testers, walk in stability chambers ( 8000 L ), GC’s constitute only a partial list of instruments available.
The laboratories for high potent compounds are isolator based designed. Two isolators meeting OEB4 and OEB5 requirement are dedicated for tablet and injectables product development. The isolator for oral solids has equipment such as rapid mixer granulator, fluidized bed drier and blenders integrated within the isolator. The isolator for injectable has also lyophilizer integrated with the isolator for transfer of vials to the lyophilzer.
A complete list can be shared with the client upon request.