White Paper

The Development, Scale-Up, And Manufacturing Of Semi-Solid Dosage Forms

Source: Cambrex
iStock-1074507482-topical-skincare-skin-

Topical products: Aim for quality, simplicity, and cost-efficiency in the development, scale-up, and manufacturing of semi-solid dosage forms

Topical products, whether prescription dermatological drugs or over-the-counter lotions, creams, or gels, present unique challenges in terms of development and manufacturing. The inherent complexity of semi-solid dosage forms derives from their composition – a mixture of an oil and a water phase in varying ratios, plus an active pharmaceutical ingredient (API) and a host of other ingredients that may include thickening/ gelling agents, emulsifiers, preservatives, antioxidants, and solvents. Additional properties of topical products also make them especially challenging to formulate and manufacture consistently. These include their mechanism of action and sensory characteristics. Mechanism of action refers to whether they are intended to act at the skin surface or to penetrate the skin layers and to what extent. The ease of application, texture, and sensory properties of topical products – how they feel, look, and smell, at first use and over time – are difficult to replicate from batch to batch. When faced with the many challenges of producing a safe, cost-effective, high-quality topical product, many companies will seek the expertise and experience of a CDMO partner.

Our drug product manufacturing and packaging capabilities cover a range of specialist dosage forms.

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