COREALIS PHARMA

FORMULATION

FORMULATION

COREALIS Pharma offers complete services for the formulation development of solid oral dosage forms – tablets, capsules, and granules. COREALIS Pharma’s experts have developed and manufactured a large variety of drug products where numerous formulation strategies and processes have been utilized. Their expertise is made available to clients for the development of the following types of drug products:

• Phase appropriate drug products for early stage clinical studies (API-in-a-bottle, API-in-a-capsule, fit-for-purpose formulations);
• Immediate release;
• Delayed and Sustained Released;
• Gastric protection;
• Sublingual;
• Effervescent;
• Combination of 2 to 3 APIs (505(b)(2));
• Reformulation of drug products for new therapeutic applications, new dosage forms or different drug loading (505(b)(2));
• Anti-drug of abuse of controlled substances.

To develop these drug products, the experts have at their disposal state of the art equipment for efficient and scalable formulation and manufacturing processes:

• Direct compression,
• Encapsulation (Powder, Tablets, Granules, Hot Melt, Suspension),
• Wet granulation (Low Shear, High shear & Fluidized Bed (FB)),
• Dry granulation (Roller Compaction),
• Melt granulation,
• Spray dry (Aqueous and Solvents),
• Drying (FB and Tray),
• Extrusion/ Spheronization,
• Hot Melt Extrusion,
• Coating (Pan and FB).

COREALIS Pharma recognises that the evaluation of the prototype formulations (in vitro and/or in vivo) is a critical part of the formulation development process and their scientists invest a lot of effort and resources in order to ensure that each and every drug products developed meets the clients’ requirements. COREALIS Pharma thrives to develop manufacturing processes that are robust, simple, cost-effective, and respectful of regulatory requirements.

The COREALIS Pharma team provides thorough service which extends to the determination of the critical manufacturing steps & parameters, establishment & justification of the finished product specifications, and a process implementation justification of the tests & specifications to be respected during production. COREALIS Pharma’s formulation development may be valid for patent approval.