Orodispersible Thin Film: A new patient-centered innovation

Gupta, Maram Suresh; Gowda, Devegowda Vishakante

doi:10.1016/j.jddst.2020.101843

Cited by 26 publications

(25 citation statements)

References 39 publications

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“…This fast disintegration property can be a particular advantage in the reformulation of antidepressants, since dysphagia is a serious and common issue in patients with mental illness [ 17 ]. Multiple studies have reported oral mucosal (buccal and sublingual) absorption of FDFs which enhance drug bioavailability via bypassing the first-pass metabolism, and avoid pre-systemic clearance [ 18 , 19 , 20 , 21 , 22 , 23 ].…”

Section: Introductionmentioning

confidence: 99%

Fabrication and Characterization of Fast-Dissolving Films Containing Escitalopram/Quetiapine for the Treatment of Major Depressive Disorder

et al. 2021

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Major depressive disorder (MMD) is a leading cause of disability worldwide. Approximately one-third of patients with MDD fail to achieve response or remission leading to treatment-resistant depression (TRD). One of the psychopharmacological strategies to overcome TRD is using a combination of an antipsychotic as an augmenting agent with selective serotonin reuptake inhibitors (SSRIs). Among which, an atypical antipsychotic, quetiapine (QUE), and an SSRI, escitalopram (ESC), were formulated as a fixed-dose combination as a fast-dissolving film by coaxial electrospinning. The resultant fiber’s morphology was studied. SEM images showed that the drug-loaded fibers were smooth, un-beaded, and non-porous with a fiber diameter of 0.9 ± 0.1 µm, while the TEM images illustrated the distinctive layers of the core and shell, confirming the successful preparation of these fibers. Differential scanning calorimetry (DSC) and X-ray diffraction (XRD) studies confirmed that both drugs were amorphously distributed within the drug-loaded fibers. The drug-loaded fibers exhibited a disintegration time of 2 s, which accelerated the release of both drugs (50% after 5 min) making it an attractive formulation for oral mucosal delivery. The ex vivo permeability study demonstrated that QUE was permeated through the buccal membrane, but not ESC that might be hindered by the buccal epithelium and the intercellular lipids. Overall, the developed coaxial fibers could be a potential buccal dosage form that could be attributed to higher acceptability and adherence among vulnerable patients, particularly mentally ill patients.

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Section: Introductionmentioning

confidence: 99%

Fabrication and Characterization of Fast-Dissolving Films Containing Escitalopram/Quetiapine for the Treatment of Major Depressive Disorder

et al. 2021

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“…They require only a small amount of saliva to dissolve in the mouth rapidly and do not need to be administered with water. In addition to their superior dosing accuracy, rapid onset of action, and convenience compared with conventional dosage forms, patient acceptance and compliance is improved, and ODFs are associated with better safety and efficacy, particularly in special patient populations such as children, the elderly, psychiatric patients, and those with difficulty swallowing [21][22][23][24]. Moreover, there is a strong patient preference for orodispersible over conventional solid or other oral dosage forms across a wide range of patient groups [21,23,24].…”

Section: Introductionmentioning

confidence: 99%

Comparative Bioavailability Study of a New Vitamin D3 Orodispersible Film Versus a Marketed Oral Solution in Healthy Volunteers

Radicioni¹,

Caverzasio

Rovati

et al. 2022

Clin Drug Investig

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Background and Objective An orally disintegrating film (ODF) formulation of vitamin D3 that dissolves rapidly in the mouth without drinking or chewing may be a worthwhile alternative to currently available drug products for therapeutic vitamin D supplementation. This study aimed to compare the bioavailability of a single dose of a vitamin D3 25000 I.U. ODF with those of a marketed oral vitamin D3 preparation in healthy subjects. Methods This Phase 1, randomised, parallel-group, open-label study compared the pharmacokinetics of calcifediol [25(OH)D3], the precursor of bioactive vitamin D3, after a single dose of a new vitamin D3 25,000 I.U. ODF with those of a Reference formulation (vitamin D3 25000 I.U./2.5 mL oral solution) in healthy adult subjects using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay. The primary objective was bioavailability under fed conditions, defined as maximum plasma concentration (C max ) of 25(OH)D3 and area under the concentration-time curve from time zero to time t, the last quantifiable concentration (AUC 0− t ). The pharmacokinetics of 25(OH)D3 were also evaluated following the ODF administration under fasting conditions. Subjects were randomised to receive a single dose of the vitamin D3 25000 I.U. ODF or the Reference oral solution under fed conditions or the vitamin D3 ODF under fasting conditions. Results Forty-eight healthy subjects were randomised and completed the study. Overall, the pharmacokinetic profile was very similar across the three treatment groups, and bioavailability did not significantly differ among treatments. Under fed conditions, mean 25(OH)D3 plasma values for C max were 6.68 ± 2.03 versus 6.61 ± 2.62 ng/mL for the Test versus Reference formulations. Corresponding values for AUC 0− t were 2364.80 ± 1336.97 versus 2150.52 ± 1622.76 ng/mL × h. Mean C max was slightly lower (6.68 ± 2.03 vs 7.23 ± 1.48 ng/mL) and the time to reach peak concentration was delayed (144 h [36–312] versus 42 h (2–480]) with the ODF under fed versus fasting conditions ( p = 0.0371). The point estimates and 90 % CIs of the Test fed /Reference fed ratios of the geometric means showed that the bioavailability of exogenous 25(OH)D3 was, both in rate and extent of absorption, slightly higher with the vitamin D3 ODF than the vitamin D3 oral solution under the administration conditions recommended for the vitamin D3 oral solution. Palatability and ease of use of the ODF were satisfactory. Conclusion The new ODF 25000 I.U. formulation provided a valuable alternative to the marketed oral solution for therapeutic vitamin D supplementation, with a bioavailability that was slightly higher ...

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“…Shown in Figure 1 is a diagram about the progress and division of orodispersible dosage during the past several decades. From a standpoint of "forms", orodispersible dosage forms have the form of tablets (such as fast disintegrating tablets [15][16][17][18][19] and fast dissolving mini tablets [20][21][22], strips (such as fast dissolving strip [23,24] and mouth melting strip [25]), fast disintegrating pellets [26] and capsules (often with fast disintegrating particles in them) [27], and many new types of films or membranes [28][29][30][31]. Based on the manufacture methods, orodispersible membranes (OMs) can be further divided into several categories, such as the most common one-solvent casting film [32,33], hot melt extrusion film [34,35], solid dispersion extrusion film [36,37], printed membrane [38][39][40][41], and the present hot topic: electrospun nanofiber membrane [42][43][44].…”

Section: Introductionmentioning

confidence: 99%

Orodispersible Membranes from a Modified Coaxial Electrospinning for Fast Dissolution of Diclofenac Sodium

Ning

Zhou

et al. 2021

Membranes

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The dissolution of poorly water-soluble drugs has been a longstanding and important issue in pharmaceutics during the past several decades. Nanotechnologies and their products have been broadly investigated for providing novel strategies for resolving this problem. In the present study, a new orodispersible membrane (OM) comprising electrospun nanofibers is developed for the fast dissolution of diclofenac sodium (DS). A modified coaxial electrospinning was implemented for the preparation of membranes, during which an unspinnable solution of sucralose was explored as the sheath working fluid for smoothing the working processes and also adjusting the taste of membranes. SEM and TEM images demonstrated that the OMs were composed of linear nanofibers with core-sheath inner structures. XRD and ATR-FTIR results suggested that DS presented in the OMs in an amorphous state due to the fine compatibility between DS and PVP. In vitro dissolution measurements and simulated artificial tongue experiments verified that the OMs were able to release the loaded DS in a pulsatile manner. The present protocols pave the way for the fast dissolution and fast action of a series of poorly water-soluble active ingredients that are suitable for oral administration.

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Orodispersible Thin Film: A new patient-centered innovation

Cited by 26 publications

References 39 publications

Fabrication and Characterization of Fast-Dissolving Films Containing Escitalopram/Quetiapine for the Treatment of Major Depressive Disorder

Fabrication and Characterization of Fast-Dissolving Films Containing Escitalopram/Quetiapine for the Treatment of Major Depressive Disorder

Comparative Bioavailability Study of a New Vitamin D3 Orodispersible Film Versus a Marketed Oral Solution in Healthy Volunteers

Orodispersible Membranes from a Modified Coaxial Electrospinning for Fast Dissolution of Diclofenac Sodium

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