.svg)
%20(2).jpg)
Oral Thin Films (OTF) have transformed the way medicines are consumed. They represent a rising market trend that is expected to exceed $9 billion by 2035, driven by consistent 8.2% CAGR growth.
Oral thin film products not only enable better patient compliance by making medication delivery simple and fast, but also expand access for pediatric and geriatric care.
As a result, better outcomes are observed when used for API with low to moderate doses, which generally do not exceed 30 mg per strip and include antihistamines and antiemetics as well as migraine medications.
However, having the right oral thin film manufacturer with experience and capability is important for pharmaceutical companies hoping to capitalize on this.
Manufacturing oral thin films at a large scale is complex. It requires the right equipment, facilities, and formulation knowledge. A reliable partner must also meet strict regulatory standards and expertly manage diverse projects. The five essential capabilities below define a dependable oral thin film manufacturer and CDMO.
OTF delivers the active ingredient effectively, whether it’s designed for immediate, sustained, or targeted release. An experienced manufacturer works with a wide range of APIs, including hydrophilic, poorly soluble, and heat-sensitive compounds, and can optimize release profiles (immediate, sustained, or buccal) to meet therapeutic goals. The right partner ensures that from pre-formulation to taste masking and polymer selection, the OTF product is effective and commercially viable.
The expertise within CDMOs enables them to provide hot-melt extrusion and solvent casting technologies, which they implement effectively with various formulation types across different production scales. They enable seamless transition from pilot to commercial production stages while ensuring consistent product quality. The advanced capabilities offered through multilayer casting and personalized thickness adjustment, together with research-stage 3D printing, enable strategic value without requiring additional infrastructure investment.
Consistency in OTFs is crucial, especially where APIs are potent or need microgram precision. CDMOs with calibrated coating lines, inline quality assurance, and statistical process control ensure every film dose meets specifications. Such accuracy has a direct return on regulatory approval and patient safety, reducing risk in development and post-launch times.
Handling of OTF requires special procedures based on factors such as temperature and humidity conditions during storage. CDMOs fulfill this purpose by combining advanced drying technology with high-quality polymer blends and premium primary packaging materials that prevent it from moisture and extend the product stability and its shelf life. They majorly focus on film stability optimization while handling packaging validation and managing the global supply chain integration for product viability.
Any pharmaceutical company needs GMP-compliant systems to obtain global regulatory approval from the US FDA, and EU (European Union), and the WHO (World Health Organization). The right partner simplifies the process through documentation management and quality-by-design practices and stability data development, which supports filing requirements. With strategic CDMOs, your OTF product will achieve streamlined access to regulated markets by leveraging their robust, audit-ready quality systems.
Selecting the right oral thin film manufacturer is a crucial decision, mainly when factors such as speed, scalability, and regulatory accuracy are essential. A pharmaceutical manufacturer specializing in oral thin film products should offer a comprehensive package, which features rapidly dissolving film formulations that enhance bioavailability, alongside in-house development capabilities for rapid prototyping and scaling up, as well as expertise in regulatory documentation on a global scale.
The ability to handle commercial production and pilot flexibly is a crucial element in supporting the various stages of a product’s lifecycle, from clinical trials to market growth. When it comes to choosing manufacturers, prioritize those that provide integrated services with robust protections for intellectual property and cooperative development models that enable you to retain rights to innovate while leveraging their technical knowledge.
Pharmaceutical companies looking to strengthen their market position or improve existing therapies with oral thin films can gain real strategic advantages that go beyond the dosage form itself.
With growing demand for OTFs, CDMOs are actively raising the bar. Here’s what’s emerging as trends:
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).
