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Excipients for Drug Formulation

Transdermal Patches: Solubilizers & Solvents

BASF offers broad portfolio of solubilization polymers and solvents that have been used in FDA-approved transdermal patches, including, the Kollidon® CL series (crospovidones or cross-linked povidones), Kollidon®s (povidones of different molecular weights).

A critical quality attribute for transdermal patches is the ability to maintain API solubilization, and prevent recrystallization, throughout the specified lifetime of the patch. There are two classes of materials that can help to achieve this objective; solvents and solubilizers. At BASF Pharma Solutions, we define these as follows:

Solvents are well known as fluids into which crystalline material can be dissolved. Depending upon the design of the patch, these fluids can be formulated into the adhesive/polymer matrix in such a way that they maintain the homogeneous solubilization of the API. Examples of fluids that have been used in approved transdermal patch products include, Octyldodecanol (Kollicream® OD), isopropyl myristate (Kollicream® IPM), Oleyl alcohol (Kollicream® OA), Polysorbate 80 (Kolliphor® PS80), Triacetin (Kollisolv® GTA) and Propylene glycol (Kollisolv® PG). For the innovator, working on new drug applications or new patch technologies other fluids may be considered. BASF has a robust portfolio of hydrophilic and hydrophobic fluids to choose from.

Solubilizers are larger polymeric molecules that may be used to disperse and/or solubilize APIs, or to retard or prevent the crystallization of the API, in the finished patch. They can do this by:

“Hosting” 

or physically holding API molecules inside their molecular structure.

Mixing 

into the adhesive polymer matrix and altering the net solubility parameter so that individual molecules of API remain dissolved.

Simultaneously acting

as the matrix for the transdermal patch film and as a solubilizer (Soluplus® and Kollidon® VA64 are known for this ability).

In our portfolio we have numerous examples of polymers that have been used in FDA-approved transdermal patches, including, the Kollidon® CL series (crospovidones or cross-linked povidones), Kollidon®s (povidones of different molecular weights, i.e. Kollidon® 12 PF, Kollidon® 17 PF, Kollidon® 25, Kollidon® 30 and Kollidon® 90 F and Kollidon® VA64 (copovidone).

Benefits

  • Wide range of solubilizers and solvents used in transdermal patches
  • Extensive expertise and understanding of topical products
  • BASF offers polymers that are being explored for use in microneedle technologies
  • Meets the highest regulatory and quality requirements

Product Overview

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Discover our portfolio of solubilizers and solvents for transdermal patches

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