Functional film properties controlled during manufacturing
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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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