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Topical Drug Formulation Development

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Topical dosage forms are medications applied directly to the body’s outer surfaces, either onto the skin or mucous membranes. These products typically come in the form of a liquid or semi-solid and have the benefit of easy drug application.

Advantages of Opting for a Topical Route of Delivery

  • Elimination of hepatic first-pass metabolism
  • Direct delivery of drug to the site of action
  • Enhanced drug efficacy in active site
  • Reduced side effects

Types of Topical Dosage Forms

Depending on the properties of the active pharmaceutical ingredients (API), target product profile, and skin treatment area, topical dosage forms can be developed as a liquid, gel, cream, lotion, ointment, and/or paste.
  • Gel: Jelly-like substances – easy to apply and leaves no residue.
  • Cream: Oil in Water emulsions (non-greasy feel) or Water in Oil emulsions (greasier and emollient)
  • Lotion: Liquid emulsions, solutions, and/or suspensions – easy to spread
  • Ointment: Oil-based preparations – creates a barrier and seals moisture to hydrate
  • Paste: Thicker than ointments – contains high proportion of solid material

Each of these dosage forms can provide optimal benefit depending on the skin condition, application location, indication, API, and patient’s preference on the feel, appearance, and ease of application.

Topical Dosage Form Development

Our scientists at Vici have a proficient understanding of how to balance between the physicochemical properties (particle size, solubility, stability profile) of APIs with those of their supplementing excipients. When selecting the appropriate excipients, factors such as functionality, drug compatibility, intended route of administration, indication, compendial status, and FDA safe limits must all be considered.

Manufacturing Process

Manufacturing topical dosage forms requires different types of equipment depending on the product specifications and production scale. Early formulation screening equipment for smaller scales may be as simple as using a mortar and pestle, ointment mill, agitator, rotor stators, and ultrasonic devices. Commercial batches can require large, heat-jacketed homogenizer tanks. At Vici, we’re well-equipped for manufacturing batch sizes suitable for early phase R&D development and manufacturing clinical supplies.

Vici’s fully equipped facilities and trained expertise is a trusted, reliable source for topical formulation development among our clients with exceptional results. Our formulation capabilities and knowledge base of regulatory requirements for both innovative and generic topical products make us your ideal CDMO partner for product development and regulatory support.

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