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Orodispersible films (ODF) are defined in the European Pharmacopoeia as “single or multilayered sheets of suitable materials, to be placed in the mouth where they disperse rapidly”. They are indicated as an appropriate form of medicine for pediatric and geriatric patients suffering from mental disorders, as well as bedridden or uncooperative patients. ODFs should be characterized by good mechanical properties and short disintegration time, as well as appropriate pharmaceutical availability of the active pharmaceutical ingredient (API). In addition, they should have a smooth surface, as well as appropriate taste and texture that do not cause an unpleasant sensation in the mouth. For this reason, during research and development, special attention is paid to disintegration time, mechanical properties, size, texture, mouthfeel after application and disintegration, as well as taste. Due to the lack of pharmacopoeial guidelines on how to assess the quality of ODF films, different standards and tests proposed in the literature are used. The disintegration time of the ODFs is indicated as key factor affecting patients’ acceptability of this dosage form. So far, many in vivo methods have been developed to assess this parameter. Among them, commonly methods, i.e. a Petri dish, a slide frame, a slide frame and ball, a pharmacopoeial apparatus, as well as novel methods, i.e. using a model of the oral cavity and a tribometer are utilized. Ensuring appropriate mechanical properties of ODFs are crucial during developing this dosage form. According to the pharmacopoeial definition, the ODFs should “possess suitable mechanical strength to resist handling without being damaged”. In order to assess the mechanical properties of ODF films, tensile strength, puncture test and tear resistance tests are carried out. The aim of this study is to present and characterized the research methods which are applied to assess the quality of ODFs, with particular emphasis on methods used for disintegration time and mechanical properties assessing.

Lopinavir (LPV) and ritonavir (RTV) are two of the essential antiretroviral active pharmaceutical ingredients (APIs) characterized by poor solubility. Hence, attempts have been made to improve both their solubility and dissolution rate. One of the most effective approaches used for this purpose is to prepare amorphous solid dispersions (ASDs). To our best knowledge, this is the first attempt aimed at developing ASDs via the electrospinning technique in the form of fibers containing LPV and RTV. In particular, the impact of the various polymeric carriers, i.e., Kollidon K30 (PVP), Kollidon VA64 (KVA), and Eudragit® E100 (E100), as well as the drug content as a result of the LPV and RTV amorphization were investigated. The characterization of the electrospun fibers included microscopic, DSC, and XRD analyses, the assessment of their wettability, and equilibrium solubility and dissolution studies. The application of the electrospinning process led to the full amorphization of both the APIs, regardless of the drug content and the type of polymer matrix used. The utilization of E100 as a polymeric carrier for LPV and KVA for RTV, despite the beads-on-string morphology, had a favorable impact on the equilibrium solubility and dissolution rate. The results showed that the electrospinning method can be successfully used to manufacture ASDs with poorly soluble APIs.

Rhinacanthins, derived from Rhinacanthus nasutus, widely used in traditional medicine, exhibit antifungal, anticancer, antiviral, antibacterial, and antiplatelet aggregation effects. Recently, their anti-diabetic activity was confirmed, which makes them an interesting natural alternative in the therapy of the early stage of diabetes mellitus. The aim of this study was to demonstrate the possibility of formulating orodispersible tablets (ODTs) and orodispersible films (ODFs) containing rhinacanthin-rich extract (RRE). Tablets with 50 mg or 100 mg of RRE were produced by direct compression. ODFs were manufactured by casting of Lycoat RS 720 or polyvinyl alcohol solution with RRE and additional excipients. The mechanical properties and disintegration times of the prepared formulations were studied. The effectiveness of taste masking was analyzed with an electronic tongue system. Six months simplified stability studies were performed in conditions complying to ICH guidelines. Appropriate friability of ODTs was achieved, despite low tensile strength (0.45–0.62 MPa). All prepared ODFs successfully met the acceptance criteria regarding Young’s modulus, tensile strength, and elongation at break. The observed variations in their mechanical properties were dependent on the type and quantity of polymers and plasticizers used. Disintegration time of ODTs ranged from 38.7 s to 54.2 s, while for ODFs from 24.2 to 40 s in the pharmacopoeial apparatus. Analyses made with the electronic tongue showed the significant taste-masking effect in both formulations. The addition of sucralose as a sweetener and menthol with mint flavor as a taste-masking agent was sufficient to mask an RRE’s taste in the case of ODTs and ODFs. Stability studies of ODTs packed in the PVC/Alu blisters showed a decrease in the RRE content below 90% after 6 months. However, ODFs with PVA were physicochemically stable for 6 months while being stored in Alu/Alu sachets. Our study proved for the first time the possibility of the formulation of orodispersible dosage forms with RRE, characterized by good mechanical properties, disintegration time, and appropriate taste masking.

In ophthalmic therapy, drugs of various structures are used, administered into the conjunctival sac or onto the cornea. Novel concepts of technological development of the form of an ophthalmic drug delivery systems include obtaining a higher concentration of the drug in the target tissue of the cornea, while reducing side effects. In recent years, there has been a growing interest in using nanofibers as a dosage forms used in ophthalmic therapy. Nanofibers prepared by the electrospinning method are characterized by high porosity, high surface area/volume ratio and good mechanical properties. For their preparation, biocompatible and biodegradable polymers are used, such as: poly-ɛ-caprolactone, polymers and copolymers of lactic acid, chitosan, gelatin, collagen, polyvinyl alcohol, polyvinylpyrrolidone. They are considered as carriers of a drug substance in order to provide its prolonged or controlled release which is essential in the treatment of chronic diseases. The improvement in the bioavailability of fluocinolone acetonide was achieved after applying inserts containing nanofibers with poly-ɛ-caprolactone prepared using the electrospinning method to the rabbit eye. Poly-ɛ-caprolactone was also used to prepare nanofibers for intravitreal administration of dexamethasone acetate in retinal diseases to achieve controlled release of the drug substance. In order to reduce intraocular pressure in the treatment of glaucoma, contact lenses coated with timolol maleate nanofibers were used. The electrospinning method was also used to prepare nanofibers gelling in situ with gellan gum and pullulan polysaccharide. On the other hand, biodegradable core-shell nanofibers composed of monoclonal antibodies, bevacizumab, may be utilized as a new form of the drug for the ADM. Natural and synthetic polymers or their combinations are also used to prepare electospun nanofibers for the tissue engineering, e.g. in corneal tissues regeneration, for the preparation of cells for implantation or for direct injection of cells into the damaged area, e.g. retina, cornea.

One of the mains factors affecting the effectiveness and safety of the therapy is the development of an appropriate dosage form adapted to the age of the patients and ease to administer as well as a dosing devices that provide flexible dosing. This approach is in accordance with the idea of patient-centered treatment. Given advantages such as safety, easy swallowing and flexible dose adjustment, special attention is paid to oral dosage forms such as orally disintegrating tablets, minitablets and orodispersible films (ODF). The ODF films are indicated as a suitable dosage form for pediatric, geriatric and uncooperative patients due to their fast disintegration in the mouth without need for water to facilitate swallowing, adhesion to the oral cavity to prevent spitting out the medicine and the ability to adjust the dose of the drug for an individual patient. According to many studies, orodispersible films are well accepted by infants and preschool children, their caregivers (nurses) and parents. They have the form of a postage stamp sized strip of thin polymeric film applied on the tongue. The ODF films can be manufactured using various methods, i.e. casting method, hot melt extrusion, electrospinning or printing (inkjet, flexographic and 3D printing) on an industrial scale and potentially in hospital pharmacies. Extemporaneous preparation of the ODF films create more dose flexibility affecting patient’s adherence to pharmacotherapy. Innovative solutions in this area concern also designed specifically devices for storage and dosing of ODF, as well as methods of labeling and identification of single doses, for example Quick Response (QR) codes. The paper presents a review of the literature from recent years regarding new technology in the terms of the ODF films preparation, including manufacturing methods and modification of the drug release, as well as the possibilities of their application in individualization of the therapy especially in pediatric and geriatric population.

Orodispersible films (ODFs) address the needs of pediatric and geriatric patients and people with swallowing difficulties due to fast disintegration in the mouth. Typically, they are obtained using the solvent casting method, but other techniques such as 3D printing and electrospinning have already been investigated. The decision on the manufacturing method is of crucial importance because it affects film properties. This study aimed to compare electrospun ODFs containing aripiprazole and polyvinyl alcohol with films prepared using casting and 3D printing methods. Characterization of films included DSC and XRD analysis, microscopic analysis, the assessment of mechanical parameters, disintegration, and dissolution tests. Simplified stability studies were performed after one month of storage. All prepared films met acceptance criteria for mechanical properties. Electrospun ODFs disintegrated in 1.0 s, which was much less than in the case of other films. Stability studies have shown the sensitivity of electrospun films to the storage condition resulting in partial recrystallization of ARP. These changes negatively affected the dissolution rate, but mechanical properties and disintegration time remained at a desirable level. The results demonstrated that electrospun fibers are promising solutions that can be used in the future for the treatment of patients with swallowing problems.