Manufacturing

Drug Delivery: Thin Dissolving Films Begin to Come of Age

Thin dissolving films (TDFs) have been in use for industrial applications for over 25 years. The first real public awareness of edible thin films was the high profile launch of Listerine Breath Fresheners, which spawned many copy cat products which consumers decided were imitation rather than an innovation, and growth of this new technology stalled. However, with the success of Suboxone film, a unique thin film application of a controlled drug ensuring increased patient compliance, TDF technology is once again being taken seriously for pharmaceutical and consumer healthcare products. insoluble actives can be suspended in films for release on dissolution in the mouth. TDFs are an ideal dosage format for the elderly, children or patients with nausea, or anyone who will not tolerate conventional tablet/ capsule dosage formats, and are now substantially cheaper to produce than ODT. Recent formulation advances are also allowing much higher dosages of API to be included in TDFs. 2) Fully Dissolving Dental/Buccal Films: Controlled release into the oral cavity or onto the teeth/gums Dental Films: Films are applied to teeth/gums and release ingredients over 10-15minutes before dissolving away e.g. teethwhitening strips, teeth re-mineralising/ sensitivity. be adapted to adhere to the mucosal wall and provide controlled release directly into the bloodstream with rapid absorption and avoidance of first pass metabolism.

TDF is a unique technology with a very broad range of product applications for oral and topical controlled release. By using the wide range of high-grade film-forming polymers now available, it is possible to produce films with an enormous range of dissolution and film characteristics. Examples of product applications for TDF are:1) Edible Oral Films: Buccal Films: Applied to the roof of the mouth the film dissolves slowly, releasing ingredients into the oral cavity and nasal passages. Ideal for volatile, decongestant ingredients. This film format is commercially marketed as Snore-eze, an antisnoring device.

3) Dermal Films: Advanced Wound Dressings: TDFs are incorporated as part of a multi-layer dressing, usually the skin contact layer, to provide controlled release of actives such as antimicrobials, antibiotics and haemostats onto the wound. TDF dissolution rates can be adjusted from rapid release into the exuding wound, or very slow titration using polymer films which are water-based but, once formed, are virtually insoluble so that after wetting they become porous to release actives very slowly over a 1-3 day period.

Temporary Skin Plaster: these are stand-alone skin coverings applied to wet skin. The TDF dissolves onto the skin surface and dries to form a temporary protective layer adhering to skin. Ingredients such as antimicrobials or anti-inflammatory agents can be included in these skin films which wash off with soap and water, and can be easily re-applied as required

Fast dissolve in the mouth within 3-10 seconds. New taste-masking techniques allow bitter ingredients to be successfully formulated, and water80 INTERNATIONAL PHARMACEUTICAL INDUSTRY

Sublingual/Mucosal Absorption: There are only a few of these mucosal and sublingual films currently marketed, but TDF technology can
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Manufacturing

Sticky Ingredients: Natural antimicrobials such as honey have been used in wound dressings as pastes for several years. Honey can be formulated into a dry film which is much easier to handle during manufacture and in patient application, but releases at the wound surface.

Conclusion: After a slightly hesitant start, thin dissolving films are beginning to come of age as a drug delivery mechanism with potential for many unique applications in pharmaceutical and healthcare products. For more information: please contact Chris Hatton, Business Development Director, BioFilm Ltd tchris.hatton@biofilm.co.uk. www.biofilm.co.uk

4) Cosmetic Films & Soaps: Face Mask: Dry thin films can be a very convenient method of applying messy ingredients to wetted skin, releasing cleansing, emollient and lightening agents. Chris Hatton is an experienced sales and marketing professional with a proven track record of business and product development in major f.m.c.g. companies and SMEs in the consumer healthcare and life science sectors. Chris was with SmithKilne Beecham (now GSK) for 20 years in senior marketing positions in the UK and overseas and was responsible for major brands such as Lucozade and Night Nurse Cold remedy. Chris moved to Scotland with RohtoMentholatum (Deep Heat, Oxy & Rohto eyecare), where he was Sales & Marketing Director for 12 years developing business through major retailers such as Boots, Tesco and leading pharmacy groups, before joining BioFilm in 2010. Email: chris.hatton@biofilm.co.uk

Packaging: Automated packing techniques have introduced pharmaceutical-style, peelopen, unit-dose, hygienically-sealed foil sachets to replace plastic multistrip dispensers. Thin Film Soaps: Surfactants, with suitable antimicrobials such as bioactive silver and emollients, can be formulated into a neat dry thin film soap which, when water is added, provides a hygienic hand and arm cleansing dosage form for medical professionals and hospital visitors. Manufacture: Techniques have evolved significantly since the early thin films launched over 10 years ago with the advent of close control of dosage and gentle drying of film which allow the formulation of heat-sensitive APIs and new tastemasking methods.
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