Formulation Development

Formulation Development


At Mascot, solid, semi-solid and liquid formulations are developed using pre-formulation data to design prototype formulations and processes. The formulation development centre also has its own validated stability chambers to conduct lab stability tests to support selection of a suitable formulation and manufacturing process.

Our offerings include:

Oral Solid Dosage Forms

Tablets
Conventional tablets – immediate release
Modified release tablets – matrix and functionally coated

Capsules
FIH formulations – drug in capsule
Formulated capsules – powder blend/granules in capsules
Modified release capsules- beads or mini tablets in capsules
Comparator development

Liquids

Oral liquids
GLP tox formulation
Solution and suspension
Powder for oral solution or suspension

Parenterals
Ready-to-use liquid and lyophilized formulations for IV, IM and SC administration

Semi-solids
Ointments, creams and gels

Analytical Method Development and Validation

Mascot offers complete analytical support for product development including QC support for cGMP activities such as validation, ICH stability studies and release testing of clinical supplies.

Our offerings include:

Analytical Method Development
Assay, purity, dissolution testing
Forced degradation studies
Cleaning verification
Microbiological testing
Stability testing and routine analysis

Analytical Method Validation
Specificity
Accuracy
Precision
Quantitation limit
Linearity
Solution stability
Detection limit
Range
Robustness
System suitability testing

Mascot’s formulation development centre has state-of –the-art infrastructure and equipment to support process development and scale-up for various manufacturing processes over a broad scale range (0.1 kg-50 kg for oral solids).

This is achieved through:
Direct compression
Dry granulation – roller compaction
Wet granulation – high shear wet granulation as well as top spray fluid bed granulation
Coating – film coat, functional coat and wurster coating for mini tablets and beads

Mascot offers expertise in utilizing the principles of Quality by Design (QbD):
Risk Assessment: Conducted for formulation as well as process parameters to identify the high risk factors that could potentially impact the critical quality attributes of the product
Experimental Design: Used for identification and optimization of processing parameters that can affect the quality of the product

Mascot offers services for manufacturing clinical supplies for oral solid dosage forms. Our 3,000 sq ft state-of-the-art clinical manufacturing facility layout is as per cGMP and schedule ‘M’ of the ‘Drugs and Cosmetics Act. It is approved by local FDA for cGMP manufacturing.

Our oral solid dosage forms capabilities include:
Scale range - 0.1 kg to 50 kg
Packaging - bottles and blister packing