Topical Formulation Product Development and Manufacturing Services

Topical Product Pre-formulation services:

• API Physico-chemical characterization: Partition coefficient, crystalline solid forms, hygroscopicity, topical dosage form for drug concentration, pH, amount of drug in the suspended form, particle size, polymorphic form, shape of particles, globule size, viscosity, and texture properties
• Molecule solubility behavior: Aqueous solubility and solubility in various ointment bases
• Molecule stability behavior: Semisolid state, forced degradation studies (acid/base, neutral hydrolysis, thermal degradation, oxidation & ICH PhotoStability, etc.)
• Molecule inherent properties: pKa, LogP/LogD
• Excipient compatibility studies and screening of excipients for formulation development
• Product characterization studies: Appearance, odor, color, homogeneity, pH, spreadability, viscosity measurements, drug content, penetration enhancer content, antimicrobial preservative content, in vitro diffusion study (Franz diffusion cell is used for drug release studies) and skin irritation study
• Product container closure system identification, selection and finalization.

We offer “Fit for purpose formulation” development for pre-clinical and subsequent stages of development.

Our expertise in chemistry helps our clients accelerate their NDA program by quick salt screening and supplying non-GMP Drug Substance (DS) and Drug Product (DP) for preclinical studies. Cross-functional teams such as PK-PD, API synthesis, salt screening, toxicology, process engineering and analytical development teams are co-located and work in an integrated manner for efficient development. Continuous feedback among the teams at each stage of the life cycle helps in resolving the issues during the early stage of NCE development and parallel activities help in expediting the timelines for product delivery.

Topical Formulation Development:

We offer development of conventional topical dosage forms such as ointment, cream, gel, lotion and dusting powder.

Topical formulation development includes the following activities but is not limited to:

• Identification, selection and optimization of formulation base/s or vehicle
• Identification, selection and optimization of formulation excipients (permeation enhancer, antimicrobial preservative, antioxidant, surfactants, emulsifiers, etc.)
• Identification, selection and optimization of process and process parameters (mixing speed and mixing time, process temperature, order of addition of excipients, etc.)
• Product Container closure system identification, selection and finalization
• Other supporting studies such as in-use stability studies, preservative effectiveness testing, compatibility and hold time studies and stability studies

Phase-I to Phase III cGMP Clinical supply/technology transfer/registration and Commercial Manufacturing: