Since its introduction in the pharmaceutical arena in the early 2000s, Oral Soluble Film (OSF) technology has been heralded for its multi-functionality and as the ultimate evolution of the oral dosage form.
OSFs are compact and a slim (nearly two-dimensional), portable, stable, non-fragile, good-tasting way to deliver a unit-dose therapeutic. OSFs are particularly appropriate for certain therapeutic areas and patient types:
For pediatric drugs, OSF solve both the swallowing difficulty of traditional tablets or capsules as well as the ‘spillability’ and general non-portability of oral liquids.
OSFs are also excellent dosage forms for geriatrics with dysphagia and also for general applications such as rescue medications.
OSF are ideal for adults where discreet use, portability and the need to avoid following the dose with water is important.
In addition, OSF products have found very successful applications in systemic drug delivery by sublingual or buccal routes to avoid GI digestion, gut-wall metabolism and hepatic first-pass metabolism.
Unfortunately, the promise of OSF was thwarted by the very high unit cost which is often 7 to 12 times that of traditional oral products like tablets, capsules and liquids.
Nova Thin Film Pharmaceutical (NTFP)’s proprietary DepoFilm™ represents a disruptive advancement in OSF drug delivery by dramatically lowering the cost of development and manufacture of these versatile dosage forms.
By solving the cost, waste and development speed problem, DepoFilm™ enables wide market adoption of easy-to-swallow OSF medications for children (or adults with dysphagia); and allows for rapid OSF product development for buccal and sublingual delivery of drugs. The DepoFilm™ platform offers compelling value for NCEs (New Chemical Entities) because it enables rapid formulation prototyping, greatly reduced development time and competitive supply costs. Rapid prototyping would even allow for buccal, sublingual and intraoral formulations in FTIM (First Time in Man) studies which in turn could be effortlessly cross-purposed for pediatric patient populations.
For more than a century, film manufacturing has been used in a wide variety of industries. The adoption of industrial film manufacturing for pharmaceutical OSF is a relatively recent development dating back to the early 2000s. NTFP has recognized that the path taken by the entire pharma industry for the manufacture of OSF using traditional solution-casting of film webs has done a disservice to the industry that has prohibited the wide adoption of OSF. NTFP is at the forefront of changing the paradigm by the intuitively simpler, more efficient methodology of film deposition.
Traditional solution film-casting or slot-die extrusion of a web are not ideally suited for batch production of pharmaceuticals due to 1) low process yield resulting from a multi-step process, 2) film tensile strength and drug uniformity issues, and 3) need for an un-reprocessable substrate. This has resulted in a very high cost per unit for OSF pharmaceuticals hampering their adoption. NTFP is at the forefront of changing the paradigm by the intuitively simpler, more efficient methodology of film deposition. Patented DepoFilm™ technology allows OSFs to be manufactured at a fraction of the cost of traditional methods by a single-step manufacturing process that avoids active ingredient and processing waste.
DepoFilm has many advantages over conventional oral thin film technology:
Higher drug loading compared to conventional soluble film
Tolerant of heat-labile API
Higher process yields
Lower energy requirements
Limitless variety of shapes
Elegant, individually printed dosage units in unit or multi-dose packaging.
Previously, an OSF would never merit consideration in early drug product development or as an FTIM Phase I clinical study formulation and was often only an afterthought as a line-extension for an ethical drug. This is not only because it is challenging and time-consuming to formulate but also very wasteful of active pharmaceutical ingredient which is available only in small quantities in early drug development.
The elegance, simplicity and cost-effectiveness of the DepoFilm™ approach will also unlock OSF product possibilities in the Consumer Health/OTC space that were previously economically unattractive.