Oromucosal film preparations: points to consider for patient centricity and manufacturing processes

ABSTRACT

Introduction: According to the European Pharmacopoeia, oromucosal films comprise mucoadhesive buccal films and orodispersible films. Both oral dosage forms receive considerable interest in the recent years as commercially available pharmaceutical products and as small scale personalized extemporaneous preparations.

Areas covered: In this review, technological issues such as viscosity of the casting liquid, mechanical properties of the film, upscaling and the stability of the casting solution and produced films will be discussed. Furthermore, patient-related problems like appearance, mucosal irritation, taste, drug load, safety and biopharmaceutics are described. Current knowledge and directions for solutions are summarized.

Expert opinion: The viscosity of the casting solution is a key factor for producing suitable films. This parameter is amongst others dependent on the polymer and active pharmaceutical ingredient, and the further excipients that are used. For optimal patient compliance, an acceptable taste and palatability are desirable. Safe and inert excipients should be used and appropriate packaging should be provided to produced films. Absorption through the oral mucosa will vary for each active compound, formulation and patient, which gives rise to pharmacokinetic questions. Finally, the European Pharmacopoeia needs to specify methods, requirement and definitions for oromucosal film preparations based on bio-relevant data.

KEYWORDS:

• Buccal film
• manufacturing
• oral soluble film
• orodispersible film
• oromucosal preparations
• patient acceptance
• viscosity

Article highlights.

• Oromucosal films are gaining increasing interest both as commercially available pharmaceutical products and as extemporaneous preparations for personalized use.

• So far, the solvent casting method seems to be the production technique of choice.

• To enhance the acceptability for the patient, oromucosal films should have an acceptable taste and appearance and should not be irritable.

• Oromucosal films should be protected by appropriate packaging to enhance their stability.

• These dosage forms should possess suitable mechanical strength, which can be defined as acceptable mechanical properties for manufacturing and handling of the films.

• Oromucosal films offer different routes of drug absorption:

  • the immediate disintegration of the film on the tongue can be considered as an oral drug delivery and absorption via the gastrointestinal route

  • whereby the application of the film onto different target sites of the oral mucosa enables local drug release and action, besides systemic action by absorption of the active substance through the mucosa.

This box summarizes key points contained in this article.

Declaration of interest

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.