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Excipients for Drug Formulation
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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

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Product Overview

Focusing on your needs with platform solutions

Discover our portfolio of solubilizers and solvents for transdermal patches

Kollicream® IPM

A fast spreading emollient with broad penetration enhancement properties for lipophilic APIs.

Kollicream® OA

A medium spreading emollient with penetration enhancement properties, and a potential solvent for lipophilic solvents.

Kollicream® OD

A medium spreading non-ester emollient which is stable against acid and base hydrolysis and provides good skin penetration.

Kollidon® 12 PF

Low-molecular grade Kollidon®, intended for use as solubilizing agent, dispersant and crystallization inhibitor particularly for injectables. In addition applicable as pore former in solid dosage forms and viscosity enhancer in parenterals.

Kollidon® 17 PF

Low-molecular grade Kollidon®, intended for use as solubilizing agent, dispersant and crystallization inhibitor, particularly for injectables. In addition applicable as pore former in solid dosage forms and viscosity enhancer in parenterals.

Kollidon® 25

Our medium-molecular povidone is used in endless ways in pharmaceutical formulations - as binder, pore former, stabilizer, thickener, as solubilizing agent, crystallization inhibitor and many more. And with our trusted quality, it will always serve exactly what you intended it for.

Kollidon® 30

Our medium-molecular povidone is used in endless ways in pharmaceutical formulations - as binder, pore former, stabilizer, thickener, as solubilizing agent, crystallization inhibitor and many more. And with our trusted quality, it will always serve exactly what you intended it for.

Kollidon® 30 LP

Our original, Kollidon® 30 in a low peroxide version - protecting your oxygen-sensitive active ingredient longer.

Kollidon® 90 F

A highly effective binder, for use as a stabilizer in oral and topical suspensions, as a thickener, and as a hydrophilizing agent or pore-forming agent in medical plastics.

Kollidon® CL-M

Kollidon® CL-M is used as a stabilizer for oral and topical suspensions and to improve the drug release characteristics of tablets, capsules or granules. Our disintegrant with micronized particles, delivers a slight disintegration functionality when used as binder. The crosspovidone is also used as pore former in some formulations.

Kollidon® VA64

Kollidon® VA64 is used in granulation and as a dry binder in tablets, capsules and granules, as a film-forming agent in tablet coatings and subcoatings, and as a film-forming agent in topical sprays. Soluble copovidone widely used for instant release formulation and is suitable in hot-melt extrusion processes.

Kolliphor® EL

BASF's non-ionic solubilizer and emulsifier for the production of semi-solid and liquid formulations of water-insoluble actives and other hydrophobic compounds.

Kolliphor® HS 15

A potent nonionic solubilizer

Kolliphor® P188

Flexible excipient to overcome a wide range of pharmaceutical challenges that provide formulators with increased efficiency and added functionality.

Kollisolv® GTA

A hydrophilic plasticizer used in both, aqueous and solvent-based polymeric coating of capsules, tablets and granules. Also used as a solubilizer and solvent as well as a humectant.

Kollisolv® PG

Manufactured under cGMP, Kollisolv® PG (1,2-propyleneglycol) can used across a wide range of applications, i.e. as plasticizer, solvent or co-solvent, stabilizer, or as carrier for emulsifiers.

Soluplus®

With its excellent capability to form solid solutions, Soluplus® is suitable for innovative processing technologies, such as hot melt extrusion. Soluplus® was awarded with the CPhI Silver Innovation Award in 2010.

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