Drug Delivery Polymers

Henkel is known throughout the world as a leading innovator in synthetic and natural polymer chemistries. Henkel’s innovations in transdermal grade adhesives have provided formulators with:

• Platforms for highly reactive drugs
• Products for extended wear
• Products that allow dispersed phase active loading
• Enhancer tolerant products
• Products that meet demanding regulatory standards

Henkel knows that quality and consistency are paramount in the pharmaceutical industry, assuring the delivery systems developer, drug marketer, and the patient that the patch will adhere and deliver the drug as designed. Henkel’s manufacturing sites are ISO certified and follow International Pharmaceutical Excipient Council (IPEC) GMP guidelines.

Detailed information on Henkel’s commercial products, including ISO-10993 suggested safety testing for intact skin surface applications, are available in US FDA Type IV Drug Master Files.

Henkel’s DURO-TAK and GELVA acrylic adhesives have a long history of use on skin and desirable solubility characteristics for a wide range of drugs, making them the adhesives of choice for many transdermal systems. With over 20 acrylic copolymers to choose from offering a variety of chemical compositions and performance properties, you are sure to find a good match for your formulation. On the other end of the solubility spectrum, Henkel’s DURO-TAK polyisobutylene and styrenic rubber adhesives give formulators even further options. Henkel is also willing to explore customized adhesive compositions for you as we recognize the many challenges new drugs bring.

Choosing the right adhesive is crucial in achieving the desired efficacy for your patch. Drug flux, adhesive loading capacity, adhesive enhancer tolerance, system stability, skin compatibility, length of adhesive wear, and even appearance are all critical to commercial success.

Henkel’s proprietary PROLOC bioadhesive technology provides a superior means to deliver therapeutic agents locally and across mucosal membranes at various absorption sites. PROLOC bioadhesives provide increased bioadhesive properties and the capacity for higher drug loading, while remaining gentle to the mucosa. PROLOC bioadhesives are prepared by a proprietary process incorporating a USP-grade amylopectin (waxy maize) and a USP-grade carbomer.

The PROLOC system can be compressed into a tablet, utilized as a powder or cast as a film. Several clinical trials have been performed to demonstrate the successful delivery of drugs across the mucosa or for local therapies using the PROLOC technology.

• Buccal
  For buccal application, PROLOC bioadhesives adhere to the oral mucosa within seconds and remain adhered until fully eroded. No backing layer is required. These bioadhesives combine high bioavailability with flexibility in tablet size, as well as films, powders or film-forming compositions.
  
• Ocular
  PROLOC bioadhesive minitablets adhere rapidly to the ocular mucosa and remain in place until fully eroded. Customers can expect long-lasting release compared to eye drops and gels, as well as resistance to gamma sterilization.
  
• Intra-Nasal
  PROLOC bioadhesive powders adhere immediately to the nasal mucosa and remain in place until fully eroded. Customers can expect high drug loading capacity and nasal residence time to maximize bioavailability.
  
• Vaginal
  PROLOC bioadhesives adhere to the vaginal mucosa within seconds and can remain adhered for several days until fully eroded. Existing oral dosage forms as well as intra-vaginal creams and gels require multiple administrations and are poorly tolerated, whereas vaginal delivery by way of PROLOC Bioadhesive offers a safe effective administration and a desired systemic effect.