Oral Dispersible Films from Product Development to End-User Acceptability: A Review.

Orodispersible films (ODFs) have served as an emerging platform for the delivery of drugs in a convenient way. They have numerous advantages, the significant one is simplicity of administration for special populations such as pediatric and geriatric as well as patients with swallowing difficulty. Besides, the advantages include accurate dosing and fast action. The ODFs are efficiently designed with detailed knowledge of drug and polymers as well as a suitable selection of method. Many conventional and advance formulation strategies have been used for the development of ODFs. The biopharmaceutical concerns of active pharmaceutical ingredients (APIs) are given in this review in light of the fact that ODFs can be utilized to increase the bioavailability of APIs. The basic critical issues such as good mechanical properties, water solubility of the API and taste masking are very important to be considered during the development of ODFs. The knowledge of critical quality concerns of ODFs will be helpful in the future development of ODF. As ODFs remain in the mouth until complete degradation, taste, texture and mouth-feel are the qualities that in all respects liable for acceptability of the patient. An assortment of packaging choices is also accessible for ODFs. This review focuses on the different critical concerns of ODF related to composition, bio-pharmaceutical, manufacturing, quality tests, packaging and acceptability. Additionally, potential barriers in the ODFs development are discussed in details. Therefore, this review is an informative bundle of ODFs concerns from the product development stage to the end-user acceptability.

Development and characterization of orodispersible film containing cefixime trihydrate.

Patients suffering from dysphagia have trouble in swallowing conventional oral dosage forms and there is also risk of choking, which may cause patient noncompliance. This study aimed to develop an orodispersible film (ODF) containing cefixime trihydrate (CFX) to cope with the above-mentioned problems as well as to enhance water solubility and masking the bitter taste of the drug. The freeze-drying and kneading methods were used for the formation of inclusion complexes. The physicochemical evaluation revealed that T7 was the best film for the incorporation of pure drug and inclusion complexes. Films were further characterized for physical and mechanical properties. Drug content, dissolving time of the film and drug release tests were performed. In vivo taste and disintegration time studies were also conducted in healthy human volunteers. FTIR spectra of the individual ingredients and prepared formulations have confirmed the chemical compatibilities of the ingredients. The solubility of CFX was increased by complexation with ß-CD and optimized freeze-dried inclusion complex (FD1) was selected for the formation of ODF. C4 was selected as an optimized film for the delivery of CFX as this film has released 95.52% drug at the end of 10 min. Dissolution kinetics of FD1 showed that it followed zero-order kinetics while drug release from films, exhibits first-order kinetics; however, both showed non-Fickian transport. In vivo taste evaluation revealed that taste was masked by inclusion complexation with ß-CD. However, selected ingredients and employed methodology enabled to formulate film, capable of delivering taste-masked CFX with improved solubility and better patient compliance.