Orally-dissolving film for sublingual and buccal delivery of ropinirole

Lai, Ka Lun; Fang, Yuan; Han, Ho Jae; Li, Qingqing; Zhang, Shuai; Li, Ho Yin; Chow, Shing Fung; Lam, Tai Ning; Lee, Thomas Wai-Yip

doi:10.1016/j.colsurfb.2017.12.015

Cited by 56 publications

(30 citation statements)

References 31 publications

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“…However, after sublingual or buccal administration of the ropinirole ODF, a fast absorption was achieved within 15 min. The bioavailability was dramatically improved by about 7fold compared to that of oral administration route (Lai et al, 2018). Similar result was also seen in selegiline.…”

Section: Discussionsupporting

confidence: 75%

Physiologically Based Pharmacokinetic Modeling to Understand the Absorption of Risperidone Orodispersible Film

et al. 2020

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The aim of the present study was to investigate the absorption routes as well as the potential application of the oral transmucosal delivery of risperidone orodispersible film (ODF) using physiologically based pharmacokinetic modeling. Methods: The pharmacokinetic study after intragastric (i.g.), supralingual, and sublingual administration of risperidone ODF was conducted in Beagle dogs. Then a mechanic absorption model which combined Oral Cavity Compartment Absorption and Transit (OCCAT) model with Advanced Compartment Absorption and Transit (ACAT) model for predicting the absorption routes of risperidone ODF in vivo was constructed using GastroPlus™. A sensitivity analysis was performed to investigate the impact of oral residence time on the in vivo absorption of risperidone ODF. Based on the fraction of intraoral absorption, the potential of the oral transmucosal delivery of risperidone were predicted. Results: There were no statistical differences in the AUC 0-t (P = 0.4327), AUC 0-∞ (P = 0.3278), C max (P = 0.0531), and T max (P = 0.2775) values among i.g., supralingual, and sublingual administration of risperidone ODF in Beagle dogs. The predicted absorption percentage via oral mucosa at oral residence time of 2 min, 5 min, and 10 min was 7.0%, 11.4%, and 19.5%, respectively. No obvious difference was observed for the bioavailability of risperidone ODF within 10 min of oral residence time. The PBPK absorption model for risperidone could be simplified to include ACAT model solely. Conclusion: The main absorption route for risperidone ODF was the gastrointestine. The absorption percentage via oral mucosa was almost negligible due to the physicochemical properties of risperidone although ODF dissolved completely in the oral cavity of Beagle dogs within 2 min.

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Section: Discussionsupporting

confidence: 75%

Physiologically Based Pharmacokinetic Modeling to Understand the Absorption of Risperidone Orodispersible Film

et al. 2020

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“…Films prepared with PEG-400 as a plasticizer (F1) showed higher percentage elongation values (89.50 ± 0.77) compared to films prepared with glycerol (F2, 67.30 ± 1.92). Overall, from the results, it can be inferred that polymer viscosities, plasticizers, and film thickness have a significant impact on the mechanical properties of MDFs [15]. MDFs with glycerol as plasticizer and MDFs casted at 40 mil thickness were brittle with poor mechanical properties compared to other formulations.…”

Section: Tensile Strength and Percentage Elongationmentioning

confidence: 87%

Development of Zolmitriptan Mouth Dissolving Films: Formulation Variables, Mechanical Properties, and in Vitro Drug Release Studies

Maddela¹,

Nalluri²

2019

Asian J Pharm Clin Res

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Objective: The objective of the present investigation is to prepare zolmitriptan (ZOL) mouth dissolving films (MDFs) and to investigate the influence of formulation variables on physicomechanical, chemical, and drug release properties of the prepared MDFs. Methods: The MDFs were prepared by solvent casting technique using wet film applicator. The impact of hydroxypropyl methylcellulose of different viscosity grades (hydroxy propyl methyl cellulose [HPMC] E3, E5, and E15), plasticizers (glycerol and polyethylene glycol [PEG]-400), and solubilizing agents (polyvinyl pyrrolidone [PVP K30] and sodium lauryl sulfate [SLS]) on physicomechanical, chemical, and drug release properties were evaluated. The MDFs were also characterized by Fourier-transform infrared spectroscopy, differential scanning calorimetry, and X-ray diffractometry studies. Results: The MDFs prepared were transparent and smooth and showed no recrystallization. The tensile strength of the MDFs increased significantly with an increase in polymer viscosities, and about a 2.63-fold increase in tensile strength was observed for HPMC E15 MDFs compared to E3, whereas an increase in film thickness resulted in brittle MDFs with low tensile strength. Similar results were observed with percent elongation and folding endurance of the MDFs. In vitro, drug release studies indicate that higher film thickness and polymer viscosities delayed the MDF disintegration and, in turn, the ZOL release. Addition of PVP K30 and SLS to HPMC E3 formulations resulted in 1.66- and 1.53-fold increase in ZOL release rates. Conclusion: Overall, F7 formulation showed quicker disintegration (within 11 s) and ZOL release rates (within 180 s) along with good physicomechanical properties. These results indicated that the disintegration and drug release of ZOL can be enhanced to a greater extent by optimizing formulation variables in MDFs.

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“…Moisture loss is the quantity of moisture transmitted through the unit area of film in unit time indicates films ability to withstand its physicochemical properties under normal conditions. 28 All the formulated films (F1-F12) were disintegrated rapidly which is a very important property of fast dissolving films. 29 In vitro, drug release studies confirmed the fast release of the drug from formulations and F6 formulation released the drug faster compared to all other formulations.…”

Section: Discussionmentioning

confidence: 99%

Fast Dissolving Oral Film of Piroxicam: Solubility Enhancement by forming an Inclusion Complex with β-cyclodextrin, Formulation and Evaluation

Dharmasthala¹,

Shabaraya²,

Andrade³

et al. 2018

JYP

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Objective: Piroxicam is a long-acting potent nonsteroidal anti-inflammatory drug (NSAID) which has a very low solubility in Gastrointesti nal (GI) fluids results in poor bioavailability after oral administration. The present investigation aimed to formulate and evaluate fast dissolving oral films containing piroxicam to overcome solubility and bioavailability problems thereby to facilitate the convenience of pediatric and geriatric patients. Method: The inclusion complexes of piroxicam with β-cyclodextrin were prepared. In vitro dissolution study was performed to fix the ratio with better dissolution rate. The selected inclusion complex was then utilized for the preparation of fast dissolving oral films by solvent casting method using sodium CMC/ chitosan as film-forming agents, sodium starch glycolate/crospovidone as super disintegrating agents. PEG 400 used as a plasticizer. Formulations (F1-F12) were prepared and evaluated for their physicochemical properties. In vitro disintegration, dissolution and permeation studies were also carried out. Results: Formulation F2 showed the minimum in vitro disintegration time (14.94±3.06 s), formulation F9 showed the maximum in vitro disintegration time (36.66±1.05 s). The formulations F6 and F4 showed better drug release of 94.4% and 92.9% respectively. Better drug permeation of 96.65% was obtained from the formulation F6 in 40 s. Conclusion: The study concluded that the fast dissolving films achieved quicker onset of action compared to the conventional preparations. The formulation found promising to obtain better therapeutic efficiency.

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Orally-dissolving film for sublingual and buccal delivery of ropinirole

Cited by 56 publications

References 31 publications

Physiologically Based Pharmacokinetic Modeling to Understand the Absorption of Risperidone Orodispersible Film

Physiologically Based Pharmacokinetic Modeling to Understand the Absorption of Risperidone Orodispersible Film

Development of Zolmitriptan Mouth Dissolving Films: Formulation Variables, Mechanical Properties, and in Vitro Drug Release Studies

Fast Dissolving Oral Film of Piroxicam: Solubility Enhancement by forming an Inclusion Complex with β-cyclodextrin, Formulation and Evaluation

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