Oral Solid Dosage Formulation Development Services

We offer extensive end-to-end services of formulation development for a wide variety of oral dosage forms. Our team assists from Prototype formulation screening studies, Formulation/process optimization using QBD principles, ICH compliant Stability studies, Scale-up/technology transfer, formulation development to development of First-in-Human (FIH) formulations to enable clinical trial studies from phase I to phase III/ commercial manufacture. We are equipped with state-of-the-art facilities to manufacture 500 to 50,000 units at R&D and up to 7,500,000 units at commercial manufacturing sites and complete CMC support for regulatory submission.

Technologies Offered

• Direct tablet compression
• Fluid bed processing (granulation, drying, coating)
• High-shear wet granulation and drying
• Dry granulation (roller compaction, slugging)
• Extrusion-Spheronization
• High-speed automated tablet compression
• Perforated pan tablet coating (mini tablets coating)
• Automated capsule filling (powder, granules, pellets, mini tablets)
• Low humidity/moisture requirements
• Light-sensitive compound handling

Immediate Release, Delayed Release, Sustained Release, Oral Disintegrating, Film-coated, Taste-masking, Fixed-Dose Combinations (FDC).

Single Layer Tablets

Depending on the mode of usage conventional uncoated or film coated immediate release tablets, orally disintegrating tablets, sublingual tablets, buccal tablets, taste masked tablets, effervescent tablets and chewable tablets can be developed.

Delayed release/ modified release tablets

Proven expertise in formulation of acid labile drugs using delayed release technology and where necessary the drug release can be modulated or targeted to release at specific regions of the gastro-intestinal tract.

Bilayer Tablets

A combination of immediate release (loading dose) and modified release portions of a single drug can be incorporated in a single dosage form. In addition, a combination of two or more drugs which may be incompatible can be formulated based on the requirement.

Mini Tablets

Fixed-dose combination (FDC) or standalone drug molecules can be formulated as mini tablets, which offer the advantage of being multi-unit particulate systems (MUPS) such as avoiding dose dumping, tailored drug release profile, targeted to release at specific regions of the gastro-intestinal tract etc.

Hard Gelatin Capsules

Powders, pellets, mini tablets or their combination can be filled into hard gelatin capsules.

Soft Gelatin Capsules

Soft gelatin capsules can be developed for liquids or suspension filling for poorly soluble and thermolabile, photosensitive medicaments.

We develop age appropriate, easily reconstitutable powders for oral suspensions, which can be filled into sachets.