Continuous manufacturing and analytical characterization of fixed-dose, multilayer orodispersible films

Thabet, Yasmin; Lunter, Dominique Jasmin; Breitkreutz, Jörg

doi:10.1016/j.ejps.2018.02.030

Cited by 31 publications

(15 citation statements)

References 16 publications

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“…AP and PVP have recently been used alone as polymers forming an ODF matrix. However, more commonly, they serve as additives, modifying the properties of matrices from other polymers, e.g., HPC and HPMC [11,[33][34][35]. A PVP with a low molecular weight (PVP K30, m.w.…”

Section: Viscosity Of the Casting Mass And Morphology Of Odfsmentioning

confidence: 99%

Technology of Orodispersible Polymer Films with Micronized Loratadine—Influence of Different Drug Loadings on Film Properties

2020

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The production of orodispersible films (ODFs) with suspended insoluble drug substances is still a challenge, mainly due to the difficulty associated with achieving a proper homogeneity and mechanical properties of the films. Hypromellose (HPMC) and a mixture of polyvinyl alcohol (AP) and povidone (PVP) were compared in terms of their suitability for ODFs incorporating suspended micronized loratadine (LO) in a concentration range of 10%–40%. In a planetary mixer (Thinky), a uniform dispersion of LO in an aqueous viscous casting solution was obtained. The suspended LO particles caused dose-dependent changes in the viscosity of the casting mass and affected the mechanical quality of ODFs. Drug concentrations higher than 30% reduced the film flexibility and tear resistance, depending on the polymer type. LO films with a thickness of 100 µm disintegrated within 60-100 s, with no significant influence of the LO content in the range 10%–30%. HPMC films, regardless of the drug concentration, met the pharmacopoeial requirements regarding the uniformity of the drug content. AP/PVP films were too elastic, and the drug content uniformity was not achieved. The conclusion is that, using an HPMC matrix, it is possible to obtain a high load of a poorly water-soluble drug (30% of dry film mass corresponds to a dose of 5 mg per 1.5 cm2) in ODFs characterized by proper physical characteristics.

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Section: Viscosity Of the Casting Mass And Morphology Of Odfsmentioning

confidence: 99%

Technology of Orodispersible Polymer Films with Micronized Loratadine—Influence of Different Drug Loadings on Film Properties

2020

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“…Various (potent) APIs can be incorporated into oromucosal films: water-soluble and poorly water-soluble small molecule drugs, biopharmaceuticals and herbal plant extracts (examples are shown in Table 1). The most common used polymers are cellulose derivates, such as hypromellose and hydroxypropylcellulose [2,39]. Furthermore, formulations with polyvinylalcohol are often mentioned in literature [9,[40][41][42][43][44][45].…”

Section: Local and Systemic Drug Deliverymentioning

confidence: 99%

Oromucosal films: from patient centricity to production by printing techniques

Tian

Orlu

Woerdenbag

et al. 2019

Expert Opinion on Drug Delivery

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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.

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“…One of the first medical devices using this technology was launched in the United States market in 2003 -Chloraseptic relief strips®, which is a fastdissolving tape containing local anesthetics for throat inflammation. The industrial production of these devices might use the assembly lines of transdermal patches (38,(40)(41)(42). Another new approach in the orodispersible technology is the production of orodispersible mini tablets (tablets with a diameter of 3 mm or less).…”

Section: Innovations In the Orodispersible Technologymentioning

confidence: 99%

The Popularization of Orodispersible Tablets in the Pharmaceutical Market

Pinho

Temer

Ribeiro

et al. 2018

Infarma

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Orodispersible tablets are getting popular due to its easy administration which leads to a higher therapeutic adherence. This study aimed to evaluate the state of the art of these drug products based on the scientific literature. Also, orodispersible tablets available in the US, Europe and Brazil markets based on information extracted from the health agencies were analyzed. Those tablets are designed to be placed on the tongue and instantly disintegrated by the fast capitation of the saliva without the additional intake of water. The orodispersible technology enables oral administration of tablets to patients with dysphagia, especially children, and elderlies. Moreover, orodispersible make possible rapid drug intervention and mouth absorption. The drug is partially absorbed in the oral cavity, pharynx, and esophagus without first pass effect, increasing drug bioavailability and reaching faster therapeutic effect. This is a low-cost technology that fits in a conventional solid production area and adds value to the product without requiring high investment. A market analysis showed there is a predominance of antihistamine drugs or medicines for mental disorders using orodispersible matrices. However, the orodispersible technology shows great versatility and potential application to other pharmacological groups. It is expected that in coming years a massive commercial insertion of this tablet technology occurs. In this scenery, it is indispensable that health professionals are prepared with updated technical information for the use of this therapeutic resource safely and efficiently. RESUMOOs comprimidos orodispersíveis têm ganhado popularidade por serem de fácil administração e levarem a uma maior adesão terapêutica. Esse estudo teve como objetivo avaliar o estado da arte desses medicamentos com base na literatura científica. Adicionalmente, foram levantados os comprimidos orodispersíveis disponíveis nos mercados dos EUA, Europa e Brasil com base em informações extraídas das agências sanitárias dessas regiões. Esses comprimidos são concebidos para serem colocados na boca e instantaneamente desintegrados pela captação da saliva, sem a necessidade de água. A tecnologia orodispersível viabiliza a administração oral de comprimidos em usuários com disfagia. Adicionalmente, esses medicamentos possibilitam uma rápida intervenção medicamentosa e absorção bucal, fazendo com que uma fração do fármaco seja absorvido na cavidade oral, faringe e esôfago sem sofrer efeito de primeira passagem, incrementando sua biodispobibilidade e permitindo alcançar um efeito terapêutico mais rápido. O barateamento dessa tecnologia, que se adapta a áreas de produção de sólidos convencionais, agrega valor ao medicamento sem demandar alto investimento.

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Continuous manufacturing and analytical characterization of fixed-dose, multilayer orodispersible films

Cited by 31 publications

References 16 publications

Technology of Orodispersible Polymer Films with Micronized Loratadine—Influence of Different Drug Loadings on Film Properties

Technology of Orodispersible Polymer Films with Micronized Loratadine—Influence of Different Drug Loadings on Film Properties

Oromucosal films: from patient centricity to production by printing techniques

The Popularization of Orodispersible Tablets in the Pharmaceutical Market

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