Patient-Centric Design in Orodispersible Films: Balancing Efficacy and Acceptability

Objective: This review paper aims to provide details on the preparation, characterization and evaluation of orodispersible films (ODFs). This review also aims to focus on the merit and demerits that affect film formulation and give an insight into potential drug candidates, and polymers used in ODFs.

Background: According to the ninth edition of the European Pharmacopoeia (Ph. Eur.), ODFs films are formulations that are intended for the delivery of drugs by oral administration via the oral cavity. From the past few decades, researchers and companies trying toward novel drug delivery systems to ensure safety, efficacy, compliance, and patient acceptability. Nowadays drug discovery and development are an expensive, complex, and time-consuming process but trends are now moving toward novel drug delivery systems. This delivery system helps to get drug response by local and systemic action through different routes. This novel approach of preparing ODFs provides ease to pediatrics, geriatrics, and bedridden patients.

Findings: Regarding formulation, ODFs must have a pleasant taste, be of appropriate size, and be packed in suitable packing material. To ensure all these properties, drugs and excipients must have good stability, the required solubility and permeability, and the dose of the incorporated drug must be small dose with a low molecular weight (MW). The manufacturing of ODFs is not an easy process and a number of techniques have been developed to manufacture them which have been discusses here. The characterization and evaluation of prepared ODFs is important, and numerous methods have been developed to assess prepared ODFs according to desired aims and objectives. Packaging of films is important to maintain stability during storage and retain the mechanical properties of ODF formulations.

Conclusion: ODFs are effective, safe, and bioavailable as compared to fast disintegrating tablets. The novel approach has various advantages because it provides effect instantly during the emergency condition and in schizophrenic and dysphasic patients without taking water and disintegrates within a few seconds in the oral cavity. Solvent casting method is the most frequently used technique to develop ODFs by using film-forming polymers having fast disintegration time, improved drug dissolution and better drug content.