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Special Issue "Orally Disintegrating Dosage Forms Based on Cyclodextrins and Hydrophilic Polymers"

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Dear Colleagues,

Orally disintegrating delivery systems (ODDSs) are pharmaceutical forms designed to rapidly disintegrate or dissolve in the oral cavity without using water. Tablets, capsules, films, patches, strips, wafers, granules, micro and nano systems or others aimed both for a local and systemic action can improve the onset of action and the compliance in children or patients with swallowing challenges. On the other hand, a low drug solubility can be a problem for an OD dosage form, not only for palatability reduction but also for drug bioavailability. Hydrophilic polymers can be employed as pharmaceutical excipients due to their ability to improve drug bioavailability, stability and acceptability, moreover, hydrophilic polymers properties can be exploited to improve ODD disintegration. This Special Issue serves to highlight the application of hydrophilic polymers in ODDs. We invite articles on all pharmaceutical dosage forms of hydrophilic polymers-based ODDs for this Special Issue.

Dr. Francesca Maestrelli
Guest Editor

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Keywords

orally disintegrating
hydrophilic polymers
drug solubility
drug dissolution

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Research

Open AccessArticle

Development of an In Vitro Methodology to Assess the Bioequivalence of Orally Disintegrating Tablets Taken without Water

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Pharmaceutics 2023, 15(9), 2192; https://doi.org/10.3390/pharmaceutics15092192 - 24 Aug 2023

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Abstract

To assess the probability of bioequivalence (BE) between orally disintegrating tablets (ODTs) taken without water and conventional tablets (CTs) taken with water, an in vitro biorelevant methodology was developed using the BE Checker, which reproduces fluid shifts in the gastrointestinal tract and drug permeation. In addition to the fluid shift from the stomach to the small intestine, the process of ODT disintegration in a small amount of fluid in the oral cavity and the difference in gastric emptying caused by differences in water intake were incorporated into the evaluation protocol. Assuming a longer time to maximum plasma concentration after oral administration of ODTs taken without water than for CTs taken with water due to a delay in gastric emptying, the fluid shift in the donor chamber of the BE Checker without water was set longer than that taken with water. In the case of naftopidil ODTs and CTs, the values of the f₂ function, representing the similarity of the permeation profiles, were 50 or higher when the fluid shift in ODTs taken without water was set at 1.5 or 2 times longer than that of the CTs taken with water. The values of the f2 function in permeation profiles of pitavastatin and memantine ODTs were both 62 when the optimized experimental settings for naftopidil formulations were applied. This methodology can be useful in formulation studies for estimating the BE probability between ODTs and CTs. Full article

(This article belongs to the Special Issue Orally Disintegrating Dosage Forms Based on Cyclodextrins and Hydrophilic Polymers)

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Open AccessArticle

Cyclodextrin-Calcium Carbonate Micro- to Nano-Particles: Targeting Vaterite Form and Hydrophobic Drug Loading/Release

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Pharmaceutics 2023, 15(2), 653; https://doi.org/10.3390/pharmaceutics15020653 - 15 Feb 2023

Cited by 1 | Viewed by 1333

Abstract

Tailor-made and designed micro- and nanocarriers can bring significant benefits over their traditional macroscopic counterparts in drug delivery applications. For the successful loading and subsequent release of bioactive compounds, carriers should present a high loading capacity, trigger release mechanisms, biodegradability and biocompatibility. Hydrophobic drug molecules can accumulate in fat tissues, resulting in drawbacks for the patient’s recovery. To address these issues, we propose to combine the advantageous features of both host molecules (cyclodextrin) and calcium carbonate (CaCO₃) particles in order to load hydrophobic chemicals. Herein, hybrid cyclodextrin-CaCO₃ micro- to nano-particles have been fabricated by combining Na₂CO₃ solution and CaCl₂ solution in the presence of an additive, namely poly (vinylsulfonic acid) (PVSA) or glycerol (gly). By investigating experimental parameters and keeping the Na₂CO₃ and CaCl₂ concentrations constant (0.33 M), we have evidenced that the PVSA or gly concentration and mixing time have a direct impact on the final cyclodextrine-CaCO₃ particle size. Indeed, by increasing the concentration of PVSA (5 mM to 30 mM) or gly (0.7 mM to 4 mM) or the reaction time (from 10 min to 4 h), particles with a size of 200 nm could be reached. Interestingly, the vaterite or calcite form could also be selected, according to the experimental conditions. We hypothesised that the incorporation of PVSA or gly into the precipitation reaction might reduce the nucleation rate by sequestering Ca²⁺. The obtained particles have been found to keep their crystal structure and surface charge after storage in aqueous media for at least 6 months. In the context of improving the therapeutic benefit of hydrophobic drugs, the developed particles were used to load the hydrophobic drug tocopherol acetate. The resulting particles are biocompatible and highly stable in a physiological environment (pH 7.4, 0.15 M NaCl). A selective release of the cargo is observed in acidic media (pH lower than 5). Full article

(This article belongs to the Special Issue Orally Disintegrating Dosage Forms Based on Cyclodextrins and Hydrophilic Polymers)

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Special Issue "Orally Disintegrating Dosage Forms Based on Cyclodextrins and Hydrophilic Polymers"

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