Why Oral Thin Film Formulation is Set to Transform Drug Delivery by 2028

Oral Thin Film Formulation

Oral Thin Film formulations have become a cornerstone in oral drug delivery, valued for their ability to deliver active pharmaceutical ingredients efficiently and reliably. Unlike other traditional oral dosage formulations such as tablets or capsules, these thin, flexible strips dissolve rapidly in the mouth. This allows the medication to be absorbed faster either through the oral mucosa or the gastrointestinal tract. Their design addresses persistent challenges in patient adherence, particularly among pediatric, geriatric, and dysphagic populations, while providing consistent dosing and rapid onset of action.

The growing adoption of OTF formulations underlines a broader shift in pharmaceutical manufacturing. The industry is becoming more patient-centric and precision-oriented. They offer manufacturers the ability to optimize release profiles, combine multiple APIs, and tailor formulations to specific therapeutic needs.

By 2028, Oral Thin Film formulations are projected to reach $7.65 billion, growing at a CAGR of 13.6%. (Source: Oral Thin Films - Global Strategic Business Report, September 2025). The focus now remains on balancing scalable production with clinical efficacy, regulatory compliance, and enhanced patient outcomes.

Market Outlook: Rapid Growth Driven by Patient-Centric Needs

Several factors are fueling the demand for Oral Thin Films, such as:

  • Ease of administration: No requirement for water, and discreet use improves patient adherence.
  • Rapid onset of action: Drugs dissolve and absorb quickly through the oral mucosa.
  • High patient compliance: Particularly beneficial for pediatric, geriatric, and dysphagic populations.

Regionally, North America leads in adoption due to strong healthcare infrastructure and regulatory support. Asia-Pacific is witnessing rising momentum, driven by expanding generic drug manufacturers in India, improving healthcare access, and growing demand for patient-friendly dosage forms (Source: Biotechnology Advances, Volume 73, 2024).

Innovations in Oral Thin Film Formulation

The evolution of OTF formulation is being accelerated by printing technologies and additive manufacturing:

  • Personalised OTFs via inkjet and 3D printing: Tailored dosing and multi-drug combinations are now feasible.
  • Solvent-free 3D printing and hot-melt extrusion: Produce amorphous films with uniform drug distribution and controlled release profiles.
  • Multilayer constructs: Allow separation of incompatible APIs and enable sequential or dual-release mechanisms.

These technological innovations not only enhance bioavailability but also provide pharmaceutical manufacturers with flexibility in product development, scaling, and compliance with global quality standards.

Benefits to Patients and Healthcare Providers

For Patients

  • Convenience: OTFs dissolve quickly without water, making them easy to administer anytime, anywhere.
  • Improved adherence: Pediatric, geriatric, and dysphagic patients experience fewer barriers to taking their medication consistently.
  • Customisable dosing: Printing technologies allow precise, patient-specific doses, including low-dose or combination therapies.

These advantages make OTF formulations particularly suitable for medications that require rapid onset, such as antiemetics, CNS drugs, or analgesics.

For Healthcare Providers

  • Flexible dosing regimens: Providers can adapt treatment plans more quickly without compromising patient comfort.
  • Multimodal delivery: Combination therapies or sequential release options reduce the number of pills needed.
  • Streamlined manufacturing: Additive technologies simplify production while ensuring consistent drug quality and regulatory compliance.

OTF formulations also bridge patient-centric design with operational efficiency, reinforcing their growing appeal across therapeutic areas.

For further insight into patient-centric design principles, see our previous blog on Oral Dosage Forms and Patient-Centric Design.

Technological Advancements Driving the OTF Market

Recent advances are addressing longstanding limitations of oral drug delivery:

  • Nanoparticle and lipid-based carriers: Improve solubility and bioavailability of poorly water-soluble drugs.
  • Multi-compartment and layered films: Enable immediate and sustained release within a single dosage form.
  • Taste-masking strategies: Cyclodextrins, ion-exchange resins, and polymer coatings increase palatability for sensitive populations.
  • Improved polymers and excipients: Enhance mechanical strength, stability, and dissolution rates, broadening therapeutic applications.

These innovations make OTFs a versatile solution for chronic conditions, acute therapies, and combination drugs, while maintaining manufacturing scalability and regulatory compliance.

Market Drivers and Global Trends

Several macro factors are accelerating OTF formulation adoption:

  • Chronic disease prevalence: Diabetes, cardiovascular, and neurological disorders require long-term adherence, where OTFs significantly improve compliance and outcomes.
  • Patient-centric focus: Convenience, portability, and ease of swallowing drive patient preference.
  • Technological innovations: 3D printing, hot-melt extrusion, and microprinting enable precision dosing and multi-drug films.
  • Emerging markets: Asia-Pacific, Latin America, and the Middle East show rising demand, supported by improved healthcare access and generics manufacturing.
  • OTC and nutraceutical applications: Vitamins, dietary supplements, and wellness products benefit from rapid absorption and discreet administration.

The COVID-19 pandemic underscored the importance of dosage forms that patients can administer themselves, with minimal need for healthcare facility visits or caregiver support.

Oral Thin Film formulations have emerged as a particularly compelling option, offering rapid, convenient, and discreet drug delivery without requiring water. For patients managing chronic conditions, pain, or mental health therapies, this ease of use reduced barriers to adherence and supported continuity of care during periods of restricted mobility.

A Future Outlook

Oral Thin Film formulations are poised to redefine how medications are delivered. Advances in 3D and inkjet printing are enabling precise, multilayered films that can combine multiple active ingredients while maintaining stability and uniformity. This translates to the ability to tailor dosage forms to specific patient needs, whether for pediatrics, geriatrics, or complex combination therapies.

At the same time, AI-driven formulation design is beginning to optimise key parameters such as dissolution rates, release profiles, and patient adherence patterns. Integrating predictive modeling with real-time manufacturing data allows pharmaceutical manufacturers to refine products faster while maintaining stringent regulatory standards.

Furthermore, quality control is becoming more dynamic. In-line monitoring and analytics help ensure consistency across batches, reducing risks and accelerating time-to-market.

By 2028, these innovations could result in Oral Thin Film formulations supporting personalised therapies, and improving bioavailability as well as patient experience, while allowing global pharmaceutical companies to respond to evolving healthcare demands with flexibility and confidence.

Frequently Asked Questions About Oral Thin Film Formulations

How do Oral Thin Film formulations improve drug bioavailability?

OTF formulations dissolve quickly and allow drugs to be absorbed through the oral mucosa, bypassing first-pass metabolism in the liver, improving systemic exposure.

Are Oral Thin Film formulations suitable for pediatric patients?

Yes. OTF formulations eliminate the need for water, reduce choking risk, and can be taste-masked for better acceptance, making them suitable for pediatric patients.

Can multiple drugs be delivered in a single film?

Multi-layer and multi-compartment films allow for combination therapies with immediate and sustained release profiles.

What manufacturing technologies are used for OTF formulations?

3D printing, inkjet printing, hot-melt extrusion, and electrospinning enable precise dosing, uniform drug distribution, and scalable production.

About ZIM Laboratories Limited

ZIM Laboratories Limited is a therapy-agnostic and innovative drug delivery solution provider focusing on enhancing patient convenience and treatment adherence to drug intake. We offer a range of technology-based drug delivery solutions and non-infringing proprietary manufacturing processes to develop, manufacture, and supply innovative and differentiated generic pharmaceutical products to our customers globally. At ZIM Labs, we provide our customers with a comprehensive range of oral solid value-added, differentiated generic products in semi-finished and finished formulations. These include granules, pellets (sustained, modified, and extended-release), taste-masked powders, suspensions, tablets, capsules, and Oral Thin Films (OTF).

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