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Oral Thin Film Formulation Development

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Oral thin films for drug delivery.

An oral thin film is a brand-new dosage form made of hydrophilic polymer that dissolves quickly in the mouth and buccal cavity. Due to its lower production costs, simple process, good compliance, and other characteristics, it has attracted more and more attention. With decades of experience and comprehensive expertise in oral thin film drug development, CD Formulation is committed to developing a full range of oral thin films to meet the needs of customers. Whether you want to develop quick-release oral thin film, sublingual thin film, non-disintegrating buccal film, fast disintegrating buccal film, or mucoadhesive sustained release film, etc. We can provide you with the best solutions for the whole process, from the determination of active ingredients, screening of inactive ingredients as well as formulation development, quality control, pilot production, packaging customization to commercial production. Our goal is to provide our customers with high quality and efficient oral thin films development to meet different needs and application scenarios.

Why Develop Oral Thin Films?

Most of the commonly used oral preparations are tablets, capsules, and pills, which need to be chewed or swallowed into the digestive tract to be absorbed before taking effect, which brings many troubles to patients with dysphagia. As a new oral drug delivery dosage form, oral thin films have the advantages of rapid disintegration in the mouth, thin thickness, lightweight, folding and tensile resistance, easy to carry, accurate dosage, etc., which can overcome the shortcomings of oral tablets, poor folding resistance and poor dose control of oral liquid preparations, effectively solve the problem of poor compliance of special patients such as children, the elderly, mental patients, etc. Therefore, there is a need for experienced oral thin films formulation development companies to develop and produce oral thin film that can meet the needs of the pharmaceutical industry, and bring more opportunities and hopes for clinical treatment.

Oral thin films for drug delivery.Fig.1 Typical oral films for drug delivery. (He M, et al., 2021)

Our Oral Thin Film Formulation Development Services

We have professional and technical personnel in the development of oral thin film drugs, which can provide you with the whole process of project supervision, to speed up the development and marketing of your oral thin films. Our researchers have conducted extensive exploration and research on oral thin film drug systems for decades and have established more than a dozen types of oral thin film formulation development techniques to meet the needs of different customers.

Importantly, our professional oral thin film pharmaceutical experts and laboratory instruments can bring you comprehensive technical services and solutions to help you achieve the integration of oral thin film drugs development to administration. Our oral thin film formulation development includes but not limited to:

Quick Release Oral Thin Film Development

Quick-release oral thin film is a new drug delivery system, that is designed to dissolve rapidly in the mouth, allowing for faster absorption of the active ingredients into the bloodstream. We provide a one-stop quick-release oral thin film development services, covering film agent screening, formula design, process development, production preparation, etc.

Sublingual Thin Film Development

Sublingual thin film refers to a drug-loaded film that is applied under the tongue and can be quickly dissolved, the drug is absorbed through the sublingual mucosa and exerts systemic effects, the therapeutic effect can be noticed within a few minutes. For low-dose, small-molecule ingredients, sublingual thin film is the best dosage form. We are committed to the development of sublingual thin film and can meet any of your needs in the development process of sublingual thin film.

Non-Disintegrating Buccal Film Development

Buccal film absorption is not affected by gastrointestinal tract excisation and is designed to deliver drugs through buccal mucosa to ensure the effect of medication. The non-disintegrating buccal film will not dissolve when it comes into contact with saliva, and the active ingredients are continuously released under control. We have many years of experience in the development of oral thin films, and our professional technical team and advanced development platform can efficiently develop the non-disintegrating buccal film.

Fast Disintegrating Buccal Film Development

Fast disintegrating buccal film is a dosage form that can quickly disintegrate in saliva and release the drug quickly. Due to its unique properties, there has been increasing research on fast disintegrating buccal film in recent years. Our fast-disintegrating buccal film development services provide an effective alternative to traditional drug delivery methods.

Mucoadhesive Sustained-Release Film Development

Mucoadhesive sustained-release film offers a good substitute way to deliver the drug and eliminate the chance of first-pass metabolism. We are dedicated to research can be used to deliver in the form of sustained release for different types of drugs which having problem like first pass metabolism. This research also can be used in future for better patient compliance, sustained or regulated release of drugs.

3D Printing Service of Oral Thin Film

3D printing as an innovative method, where thin layer of drug loaded dispersion is printed and dried before printing of subsequent layers, Layer-by-layer drying as the in-process step improves mechanical properties of films, uniformity of drug content and allows faster preparation of films in compounding settings due to shortening of drying time. We have professional developers of oral thin films and 3D printing technology platform, which can be customized according to the needs of patients.

Single-Layer Oral Thin Film Development

Single-layer oral thin film is a thin film composed of polymer containing 1 layer of drug carrier. The released drug components enter the bloodstream through the oral mucosa and esophageal tissues and take effect rapidly. We have a professional oral thin film formulation development technical team, which analyzes the oral film from various aspects such as formulation process and quality control, so as to develop high-quality single-layer oral film.

Double-Layer Oral Thin Film Development

The double-layer oral film is characterized by its double-layer structure, one layer is a slow-release drug-loading layer, and the other is a waterproof protective layer, which prevents the reverse release of drugs, and has the characteristics of isolating saliva and external erosion for a long time to prevent the dissolution of drugs. The double-layer oral thin film provides a new alternative to traditional drug delivery and is a major breakthrough in traditional drug delivery technology.

Multi-Layer Oral Thin Film Development

Multi-layer oral film, also known as compound oral film, are made up of multiple layers of drug films, which can solve the problem of drug compatibility. In addition, they can also be prepared into sustained-release and controlled-release film preparations. It is favored by drug developers and patients because of its rapid onset of action and high bioavailability. We are committed to the development of multi-layer oral film formulations based on advanced technology platforms and professional drug development expertise.

One / Several APIs Oral Thin Film Development

Oral thin films can carry various kinds of APIs, but due to the limitation of dosage form size, oral thin films are difficult to carry high doses of active ingredients. We have a variety of methods to increase the oral film loading capacity and has many years of experience in the development of one/ several APIs oral thin film formulations.

Novel Solvent-free Oral Thin Film Development

The development of oral thin films using novel solvent-free methods is the main goal of current research on oral thin films, aiming to solve the challenge of patients swallowing the whole or part of the films and allowing the drug to enter the gastrointestinal tract. We have experience in preparing different types of films using novel solvent-free methods. our experienced team of experts can provide you with professional advice no matter what stage you are at.

What Problems Can We Solve?

  • Oral Thin Film Formulation Development: Including conduct preformulation studies to assess the compatibility of the API with different excipients, etc.
  • Oral Thin Film Process Development: Including API screening and characterization, inactive Ingredient evaluation, and preparation method screening.
  • Oral Thin Film Characterization: Including appearance and physicochemical characterization, properties biological properties evaluation.
  • Oral Thin Film Efficacy Evaluation: Including preclinical studies, pharmacokinetic and pharmacodynamic evaluation, stability testing.
  • Oral Thin Film Manufacture: Including formulation scale-up and manufacturing process optimization to ensure consistent product quality and performance.

Our Advantages in Oral Thin Film Formulation Development

  • Customized Solutions: We can provide customized solutions according to customer requirements.
  • Professional Development Services: We provide compliant, high quality, reliable and efficient service to help partners shorten the R&D cycle, reduce trial and error costs, accelerate product registration and market launch.
  • Advanced Oral Thin Film Development Platform: We have a strict oral thin film drugs development environment, high-tech instruments and equipment, and a complete experimental platform.
  • One-stop Development Services: We have been in the oral thin film drugs field for many years and have rich project development experience in the industry, which can provide one-stop research and full project management services.

With our cutting-edge new drug delivery technology platform, CD Formulation offers a comprehensive suite of oral thin film delivery systems development services, including formulation design and optimization, preformulation studies, excipient selection, stability testing, and scale-up and production, etc. If you have a requirement about our oral thin film formulation development services, please contact us by phone or email, our colleagues will reply to you within three working days.

References

  1. He M, Zhu L, Yang N, et al. Recent advances of oral film as platform for drug delivery. Int J Pharm. 2021, 604:120759.
  2. Sevinç Özakar R, Özakar E. Current Overview of Oral Thin Films. Turk J Pharm Sci. 2021, 18(1):111-121.
  3. Jiaxiang Zhang, Anqi Lu, et al. Development and Evaluation of Amorphous Oral Thin Films Using Solvent-Free Processes: Comparison between 3D Printing and Hot-Melt Extrusion Technologies. Pharmaceutics. 2021, 13(10), 1613.
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CD Formulation, an expert in novel oral thin film delivery systems, is dedicated to supporting pharmaceutical companies in developing and commercializing innovative drug formulations...

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