Formulation Development
We are experts in the development of solid, semi-solid, and paranteral dosage forms
PSS excels in the formulation development of a variety of active pharmaceutical ingredients (API), including drug products that are challenging to stabilize or solubilize.
We are experts in common routes of drug delivery (tablets, capsules, liquids, injectables) and specialize in more innovative and complex delivery systems including: Immediate Release, modified release polymeric controlled release, in situ forming gels, Technology platforms improving APIs solubilities (like Solid solution, Hot Melt Extrusion, Lipid Based Formulation, Spray Drying, suspensions, etc.) to overcome your development challenges and maximize the safety and efficacy of your drug product. Our expertise and the capabilities of our network include the identification and preparation of drug product prototypes in GMP pilot plants for in vitro and in vivo studies (first in Human or for a pilot PK study in case of Generic plus formulations).
The formulation and analytical development consultancy support services at PSS help product developers, manufacturers and entrepreneurs transfer innovative ideas into approved products.
Our Formulation Expertise Includes:
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Pharmaceutical Formulation Development of traditional (tablets, capsules, pellets, granules, liquids, injectables) and complex (long-acting, controlled release, suspensions) dosage forms
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Reformulated drug products to increase shelf life
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Formulations with combinations of drugs (two or more pharmaceutical ingredients)
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Specific expertise in formulation low soluble compounds (Spray Drying, HME and lipid based formulations)
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Use of non-aqueous vehicles for hard-to-solubilize drugs
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Development of long-acting injectable formulations utilizing accepted controlled release technology
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New chemical entities and repurposed drugs with high potency, low solubility, poor stability, or that may require segregation from other manufacturing operations such as hormones, etc..
