# DEPOFILMTM - A NOVEL AND EFFICIENT METHOD FOR PRODUCING ORAL SOLUBLE FILM FOR DRUG DELIVERY

> **NIH NIH R43** · NOVA THIN FILM PHARMACEUTICALS LLC · 2021 · $256,560

## Abstract

Project Summary-Nova Thin Film Pharmaceuticals LLC
NOVA Thin Film Pharmaceuticals’ (NTFP) mission is to unlock the full economic & therapeutic potential of the
orally soluble film (OSF) dosage form. OSF pharmaceutical products were first introduced in the early 2000s &
are particularly appropriate for certain therapeutic areas & patient types. The ability to swallow an OSF easily
without water combined its portability made it particularly apropos for pediatric patients as well as adults or
geriatrics with dysphagia. 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. The limitation to widespread use of OSF has always been the cost and waste associated with the
traditional solution film-casting process used in their manufacture which also makes rapid formulation
prototyping difficult. NTFP’s approach involves our patented film-by-deposit system (DepoFilm™), which
offers dramatic efficiency and cost advantages over the existing standard manufacturing methodology.
DepoFilm™ is an integrated process for film manufacturing & packaging. The film former solution & drug are
deposited and dried in wells that are part of a web that comprises the final package of the product. At the end of
the drying cycle, a heat-sealable aluminum laminate ‘lidding’ sheet is applied to complete primary packaging.
Yield loss is limited to very minor handling loss – we expect yields in the range of 96-98% which could even be
superior to some types of tablet and capsule manufacturing processes involving multiple unit operations.
Nova will license DepoFilm technology and offer product development services to ethical pharmaceutical
companies seeking to develop OSF formulations of 1) pediatric and/or adult formulations of their existing or
pipeline drugs, 2) drugs requiring buccal or sublingual delivery to avoid GI tract or first-pass metabolism & 3)
other suitable drug candidates for which portability and non-requisite water intake are desired attributes e.g
acute or rescue indications. NTFP would work with client companies to develop & manufacture OSF
formulations for approval using the 505(b)(1) or 505(b)(2) New Drug Application pathway. The elegance,
simplicity & cost-effectiveness of our approach will also unlock OSF product possibilities in the Consumer
Health/OTC space that were previously economically unattractive.
Our management team is composed of a group that essentially created the modern pharma OSF industry.
Joseph & Richard Fuisz helped start the thin film drug delivery sector, inventing the largest patent portfolio for
pharmaceutical OSF by solution-casting & co-founding MonoSolRx/Aquestive Therapeutics. Madhu Hariharan
is a drug delivery expert who worked on thin film at MonoSol Rx, has several OSF patents, & through his
consulting company Solvekta, has worked on virtually every major pharma film product launch to da...

## Key facts

- **NIH application ID:** 10138145
- **Project number:** 1R43GM140539-01
- **Recipient organization:** NOVA THIN FILM PHARMACEUTICALS LLC
- **Principal Investigator:** Madhu S Hariharan
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $256,560
- **Award type:** 1
- **Project period:** 2021-04-01 → 2022-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10138145

## Citation

> US National Institutes of Health, RePORTER application 10138145, DEPOFILMTM - A NOVEL AND EFFICIENT METHOD FOR PRODUCING ORAL SOLUBLE FILM FOR DRUG DELIVERY (1R43GM140539-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10138145. Licensed CC0.

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