PREFORMULATION

Formulation

Sample of Formulation Development Outline

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

Formulation and Development

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