Piramal Pharma

Formulation Development

Piramal has the expertise and a demonstrated history of formulating a wide range of finished pharmaceutical products. Our Morpeth, Pithampur and Sellersville sites support the development of conventional oral solids. Sellersville also supports development of liquids, creams and ointments and our Lexington facility provides development capabilities for sterile injectables. Additionally, our Centre of Excellence for Formulation Development at Ahmedabad integrates well with our formulation sites and has tremendous expertise in pre-formulation studies and formulation development to help you select the ideal dosage form. We understand that each drug product is unique, and the scientific teams at Piramal are capable of delivering tailored solutions to tackle the most complex development challenges.

Formulation Services

BROCHURE

Featured Services

Unlock the potential of your pharmaceutical development with our comprehensive Pre-Formulation Studies. Our tailored services, utilizing small quantities of Active Pharmaceutical Ingredients (API) or druggable candidates, offer invaluable insights and expertise to guide compounds towards the next stages of development.

Pre-Clinical Candidate Characterization
- Solubility Analysis: Involves analysis of pH solubility profile, solubility in organic solvents, solubility in fasted State Simulated Intestinal Fluid (FaSSIF), Fed State Simulated Intestinal Fluid (FeSSIF), and Simulated Gastric Fluid (SGF)
- Stability Assessment: Solution and Solid-State Stability, ICH Photo Stability
- Inherent Properties: pKa, Log p/Log D, Intrinsic Dissolution
- Design of Experiments (DOE) Based Screening: Solvent, Buffer, Ionic Strength, and Stabilizer Excipient Screening for Formulation Development
Formulation Development for Testing:
- Vehicle Selection
- pH Adjustment and Co-Solvent
- Surfactant Solubilization
- Nano-Suspension
- Micro-Emulsion
- Amorphous Solid Dispersions

Clinical Phase Analytical Support – Drug Product
- Solid-State Characterization
- Analytical Methods Development and Transfer
- Analytical Method Validation
- Dissolution Assay Development and Testing
- Stability Studies: Accelerated and Full ICH
CMC support service:
- Solid-State Characterization: Includes PXRD, TGA, DSC, Polarized Light Microscope (PLM), Dynamic Vapor Sorption (DVS/Hygroscopicity), and Particle Size Analysis (PSA)
- Polymorph Screening: Identification of Multiple Polymorphs to Ensure Thermodynamic Stability
- Crystallization Process Development: Polymorphism Investigation , Crystal Size Distribution Measurement, Drying Investigation to Deliver API with Desired Properties
Formulation Support:
- Formulation Support:
- Micrometrics (Powder Properties Evaluation)

We offer analytical support services for oral solids, liquids, creams, ointments and sterile injectables from our facilities in the US, UK, and India. As a leader in integrated solutions, we seamlessly engage our global sites to conduct drug development work in parallel, accelerating time to market and reduce costs for our customers.

Raw materials and API testing:
- Chemical: Solubility (equilibrium/kinetic), hygroscopicity, thermal behaviour, log P, and stability.
- Physical: Microscopy, particle size
Pre-formulation:
- Solubility
- Forced degradation
- Particle size
- Excipient Compatibility
- Fast content uniformity
Formulation:
- We are experienced in analytical methods development, validation and transfer, moisture content testing (KF and LOD), particle size distribution, finished product testing, cleaning validation, stability studies and a whole host of other tests

Stability Studies:
- We currently offer stability programs with chambers covering -20°C, 2.8°C, 25°C/60%RH, and 40°C/75%RH, as well as an R&D photostability chamber. Our wide variety of testing services, according to the International Conference on Harmonization (ICH) guidelines, will equip you with the data needed for your filing.
Analytical (Microbiology) :
- Environment Monitoring of classified areas
- Microbiological analysis of Water
- Microbial enumeration test
- Stability Studies along with preservative efficacy testing
- All testing as GLP requirements.