Dissolvable Films: Dissolvable Films for Flexible Product Format in Drug Delivery - Pharmaceutical Technology

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Dissolvable Films: Dissolvable Films for Flexible Product Format in Drug Delivery
For pediatric and geriatric patients, fast-dissolving drug-delivery systems provide an easier way to take medications and vitamins. Oral thin films have evolved to provide systemic delivery of active pharmaceutical ingredients for over-the-counter and soon, prescription drugs. The authors review the practical benefits of dissolvable films, their manufacture, and their market potential.

Pharmaceutical Technology

Functional film properties controlled during manufacturing
In addition, the benefits of the technology continue to be studied. Some drug substances may be absorbed more rapidly through the oral mucosal and esophageal tissues via OTF formats during ingestion. Because the drug enters directly into the bloodstream and avoids hepatic first-pass metabolism, bioavailability may be improved, and the drug can be administered in smaller doses. Smaller doses translate to fewer side effects and potentially improved patient compliance. Oral mucosal delivery via OTFs could become a preferential delivery method for therapies in which rapid absorption is desired, including those used to manage pain, allergies, sleep difficulties, and central nervous system disorders.

Benefit-driven development

The combination of the current platform capabilities, in conjunction with known and emerging benefits, suggests significant market potential for dissolvable films. According to the 2006 Technology Catalyst, Inc. (TCI) report, it is anticipated that the OTF market could reach $500 million this year and approach $2 billion in 2012. These estimates are contingent upon the launch of OTC formats in new categories such as smoking cessation products and the expected launches of generic and branded prescription drugs (3). We anticipate dramatic growth for OTFs over the next five years given several factors:

  • The benefits of the thin-film format (fast, accurate, safe, and well-tolerated) are widely known and accepted by consumers (4)
  • The development of thin-film prescription drugs are already in the early- to mid-development stages
  • OTFs could potentially replace some orally dissolving tablets (ODTs) as a competitively priced alternative (3)
  • Consumer studies indicate patients prefer a fast-dissolving product over a standard tablet (5)
  • OTFs may provide drug manufacturers with significant opportunities in life-cycle management, market expansion, and product differentiation
  • Acceptance of OTF technology in the OTC market has led to significant improvements in development cycle time with products potentially developed and launched within 12–16 months.

The TCI report forecasts growth only for the extension of OTF technology in oral immediate-release applications. The total market size expands if film technology is extended into emerging controlled-release and dermal or transdermal applications.

Looking forward, there is speculation as to how generic and branded drug manufacturers will strategically introduce the OTF format, particularly given the erosion of branded ODT products to their generic counterparts. The potential exists for some manufacturers to bypass the launch of ODT products and move directly to the development of OTFs, particularly in generic products and profitable branded-product platforms (3). This approach has some regulatory merit, as the US Food and Drug Administration stated that an OTF abbreviated new drug appliation (ANDA) may be submitted as an alternative dosage form for a chewable tablet. This statement, was made in conjunction with an approved suitability petition for an ANDA for famotidine orally dissolvable film in a 10-mg dose (6). Future suitability petitions for ANDAs using OTFs to substitute for ODTs can be expected (3).

Strategic therapeutic categories . OTF formats can be considered for any therapeutic category in which an oral solid, liquid, or ODT format is currently offered. Ideal applications are those that use drug compounds that are potent and possess a narrow therapeutic range (7). In addition, OTFs are proven to be a more beneficial platform for compromised populations such as children or the elderly where a quick, well-tolerated platform aids administration (8).

From a strategic standpoint, a group of therapeutic categories stand out as leading applications for the OTF format to expand beyond commercial OTC products on the market today (see sidebar, "Strategic therapeutic categories for oral thin films"). Development of a branded prescription OTF product for smoking cessation would set a precedent for the format, much like the launch of transdermal drug delivery patches for smoking cessation did in the 1990s.


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