Publication

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

Krampe, R., Visser, C., Frijlink, H. W., Breitkreutz, J., Woerdenbag, H. J. & Preis, M., 2-Apr-2016, In : Expert Opinion on Drug Delivery. 13, 4, p. 493-506 14 p.

Research output: Contribution to journalReview articleAcademicpeer-review

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.

Original languageEnglish
Pages (from-to)493-506
Number of pages14
JournalExpert Opinion on Drug Delivery
Volume13
Issue number4
Publication statusPublished - 2-Apr-2016

    Keywords

  • MUCOADHESIVE BUCCAL FILMS, DRUG-DELIVERY-SYSTEMS, ORAL DOSAGE FORMS, ORODISPERSIBLE FILMS, POLYMERIC FILMS, VIVO EVALUATION, SOLUBLE FILM, BIOADHESIVE FILMS, IN-VITRO, FORMULATION

ID: 26964847