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Single-Layer Oral Thin Film Development

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Single-layer oral thin film is a thin film composed of a polymer containing a single-layer drug carrier. The released drug components enter the bloodstream through the oral mucosa and esophageal tissues and take effect rapidly. CD Formulation has professional oral thin film formulation development technical teams, which analyze the oral thin films from various aspects such as formulation process and quality control, to develop high-quality single-layer oral thin film.

Why Develop Single-Layer Oral Thin Film?

Single-layer film is a kind of film that is widely used in clinical applications. Its preparation method is simple. It is usually a film formed by dispersing drugs in a film-forming material, which can be divided into two categories: soluble oral thin film and water-insoluble oral thin film. The thickness generally does not exceed 1mm, and the area of the film can be adjusted according to the dosage. Films generally used for oral administration are less than 1cm.

  • Simple production process, easy to automate and aseptic production.
  • Accurate drug content, stable quality.
  • Easy to use, suitable for a variety of drug delivery routes.
  • Small size, light weight, easy to carry, transport and storage.

Our Single-Layer Oral Thin Film Development Services

Screening of Film Materials

As the carrier of drug, the film-forming material plays an important role in the forming and quality of single-layer oral thin film. Therefore, the screening of the film-forming material is crucial. The film-forming material must be stable, have no unpleasant odor, not affect the efficacy of the drug, and not interfere with the content determination of the drug and the film made has a certain tensile strength and flexibility. We have strong external procurement teams and film-forming materials testing capabilities to ensure the reliability of raw materials and select the most suitable film-forming materials.

Preparation Method

Casting technology is the most commonly used film-making technology for single-layer oral thin film, usually the film-forming material is dissolved in the appropriate solvent filtration, and the drug active ingredients and additives are fully mixed into the pharmaceutical pulp, and then the film is coated with the required thickness, after drying according to the content of the main drug to calculate the area of the unit dose of the film, cut it into small grids for a single dose, and packaging.

Quality Control

Our experienced technicians carry out comprehensive quality control, including physicochemical characterization, development and validation of analytical methods, stability testing, etc.

Fig.1 Development process of single-layer oral thin films.Fig.1 Process of Single-layer Oral Thin Film Development. (CD Formulation)

Our Platforms for Single-Layer Oral Thin Film Formulation Development

Technologies Specifics Contents
Casting Technology Casting is the most used preparation technology. The process is to dissolve or suspend film-forming materials, raw materials, and other auxiliary materials in suitable solvents. The air bubbles are removed after mixing evenly, and then cast on the mold or coated with film forming agent and cut and package after drying.
Scanning Electron Microscope (SEM) Technology A SEM is a type of electron microscope that produces images of a sample by scanning the surface with a focused beam of electrons. SEM imaging was used to show the surface morphology of the films.
Fourier Transform Infrared Spectroscopy (FTIR) FTIR spectroscopy is a powerful and widely used technique for studying an extensive range of substances, including investigations of their nature and behavior under a gamut of conditions. The prepared films are analyzed by Fourier transform infrared spectroscopy to examine the interaction between the active ingredient and the excipients.

Our Advantages in Single-Layer Oral Thin Film Development

  • Advanced technology platform: We have state-of-the-art facilities and equipment for developing and testing single-layer oral thin films.
  • Speciality: We use innovative technology to develop a single-layer oral thin film formulation that provides good taste, acceptable sensory properties, and is flexible enough, thin and of appropriate tensile strength to guarantee patient compliance.
  • End-to-End Services: We provide end-to-end services, from pre-formulation research to commercial production to ensure customers can bring their products to market as quickly as possible.

Published Data

Technology: Single-layer pH-sensitive films for colon-specific delivery

Journal: International Journal of Pharmaceutics

IF: 5.8

Published: 2019

Results: This study designed a single-coat pH-sensitive layer for colon-specific delivery with a potential biopolymer, namely, zein. A scanning electron microscope (SEM) was used to study the surface characteristics of the coating layers, and Fourier transform infrared spectroscopy (FTIR) was used to investigate the molecular interactions between these coating materials.

Fig.2 Single-layer film for targeted oral delivery to the colon.Fig.2 A single-layer film coating for colon-targeted oral delivery. (Minh N.U. Nguyen, et al., 2017)

CD Formulation provides integrated innovative solutions from strategy to implementation to help you increase opportunities and meet challenges. Through our deep experience in the field of oral thin films, we bring innovative solutions and cross-industry best practices to single-layer oral thin film development. If you have any requests for our single-layer oral thin film development services, please contact us by phone or email and one of our colleagues will get back to you within three working days.

References

  1. Maram Suresh Gupta, Tegginamath Pramod Kumar, et al. Formulation and Evaluation of Oral Fast Dissolving Film of Glibenclamide. Journal of Drug Delivery Science and Technology. 2020; Vol (59).
  2. Minh N.U. Nguyen, Phuong H.L. Tran, et al. A single-layer film coating for colon-targeted oral delivery International Journal of Pharmaceutics. 2019, Vol (559):402-409.
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