Oromucosal films: from patient centricity to production by printing techniques

Abstract

Introduction: Oromucosal films, comprising mucoadhesive buccal films (MBFs) and orodispersible films (ODFs), are considered patient-centric dosage forms. Target groups are patients with special needs. Various active pharmaceutical ingredients have been shown to be suitable for oromucosal film production. A shift is seen in the production techniques, from conventional solvent casting to printing techniques. Areas covered: In this review, the patient acceptability of oromucosal films is discussed. An overview is given of the small molecule drugs, biopharmaceuticals and herbal extracts that have been incorporated so far. Finally, the current state of 2D and 3D printing techniques for production purposes is discussed. Expert opinion: The patient-centric features are important for the further development and acceptance of this oral solid dosage form. Oromucosal films perfectly fit in the current attention for personalized medicine. Both MBFs and ODFs are intended for either a local or a systemic effect. For buccal absorption, sufficient mucoadhesion is one of the most important criteria an oromucosal film must comply with. For the preparation, the solvent casting technique is still predominately used. Some limitations of this production method can be tackled by printing techniques. However, these novel techniques introduce new requirements, yet to be set, for oromucosal film preparation.

A Pediatrics Utilization Study in The Netherlands to Identify Active Pharmaceutical Ingredients Suitable for Inkjet Printing on Orodispersible Films

“…Vaccines are prone to degradation if taken orally and if exposed to high temperatures. They can, however, be stabilized with sugars, subsequently incorporated into ODFs and are absorbed via the buccal or sublingual route upon administration [13]. The printing of vaccines via inkjet printing is, because of the usually high temperatures involved, not possible.…”

“…In the first step, medications that could not be identified because of an incomplete ATC code (e.g., only having a first level ATC code available in the database), had no legal status as drugs or were mentioned more than once in the pharmacy dispensing database (duplicates) were excluded. Furthermore, as the drug load per ODF is limited [13], all of the medications with a maximum drug load of more than 50 mg per dose were also excluded. The primary source for establishing the dose was the Dutch pediatric formulary [16].…”

“…Besides this method, printing techniques are suitable for the incorporation of APIs onto ODFs, yielding a personalized oral dosage form [11,12]. Inkjet printing is an emerging technology in the pharmaceutical area, used for the direct labelling of dosage forms, but is also suitable for the API deposition [13]. The significant advantage of this technique is the flexible and precise deposition of the API on a substrate (such as a plain ODF) suitable for small-scale and continuous production [14].…”

Orodispersible films (ODF) in individualized therapy

“…[16,17] Chlorowodorek betahistyny Inkorporowanie do żywicy jonowymiennej (Amberlite ® IRP-69) PVA, glicerol [18] Melatonina Sporządzenie mikrocząstek lipidowych na bazie uwodornionego oleju rycynowego Maltodekstryna, Span 80, Tween 80, glicerol [19] W ostatnich latach przedmiotem zainteresowania jest stosowanie techniki druku do wytwarzania filmów ODF. Metoda druku atramentowego 2D polega na naniesieniu roztworu lub zawiesiny substancji leczniczej na filmy otrzymywane metodą wylewania na bazie celulozy lub skrobi, a także na papier ryżowy, lukier oraz folie z poli(tereftalanu etylenu) (PET) (rycina 2) [6,20,21]. Technikę zastosowano do wytwarzania filmów zawierających substancje silnie działające o niskim indeksie terapeutycznym, ze względu na precyzję wydruku [22].…”

“…Z tego względu proponuje się dodatek substancji zwiększających porowatość filmów bazowych, np. mezoporowatej krzemionki koloidalnej, w celu zwiększenia ich właściwości absorpcyjnych, co umożliwia wprowadzenie większej dawki substancji leczniczej bez wystąpienia efektu rozsmarowywania [21,23].…”