Formulation Development
NextPharma PDS provides pre-formulation evaluation and formulation development services for oral solid, semi-solid, liquid and parenteral dosage forms of both small molecules and biologics.
Pre-formulation evaluation services include:
- pKa determination
- Partition coefficient
- Chemical stability profile
- Solubility determination
- Crystal properties and polymorphism (DSC, XRPD)
- Particle size, shape and surface area
Formulation Development Capabilities include:
| DOSAGE FORM | AVAILABLE FORMS | CHARACTERISTIC | OTHER FEATURES |
| Solid Dosage | Tablets | Uncoated tablets | |
| Film coated tablets | |||
| Effervescent tablets | |||
| Capsules | Hard capsules | Granulation available | |
| Pellet | Immediate release | ||
| Extended release | |||
| Gastric-resistant release | |||
| Powder | Lyophilized sterile or non-sterile |
||
| Non-sterile | |||
| Semi-solid Dosage | Ointments | Non-sterile | filled in tubes and single dose-units |
| Creams | Non-sterile | filled in tubes and single dose-units | |
| Gels | Non-sterile | filled in tubes and single dose-units | |
| Liquid Dosage | Solutions | Sterile or Non-sterile (oral and topical) |
Aqueous or solvent based |
| Emulsions | Sterile or Non-sterile (oral and topical) |
Aqueous or solvent based | |
| Suspensions | Sterile or Non-sterile (oral and topical) |
Aqueous or solvent based |
Process Validation
- Manufacturing of development trial batches
- Stability testing of trial batches
- Selection of optimal formulation
- Scale-up and from laboratory-scale to pilot scale and then to production scale batches
- Manufacturing process validation
- Technology transfer
We can offer the following specialist technologies:
- Hormones (oral and topical)
- Steroids (oral and topical)
- Antibiotics (oral) including Penicillins and Cephalosporins
- Lyophilization
- Biologics (proteins, antibodies)
- Controlled drugs