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      Formulation of sublingual promethazine hydrochloride tablets for rapid relief of motion sickness

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          Abstract

          The delivery of antihistaminic agents via the oral route is problematic, especially for elderly patients. This study aimed to develop a sublingual formulation of promethazine hydrochloride by direct compression, and to mask its intensely bitter taste. Promethazine hydrochloride (PMZ) sublingual tablets prepared by direct compression were optimized using Box-Behnken full factorial design. The effect of a taste-masking agent (Eudragit E 100, X1), superdisintegrant (crospovidone; CPV, X2) and lubricant (sodium stearyl fumarate; SSF, X3) on sublingual tablets’ attributes (responses, Y) was optimized. The prepared sublingual tablets were characterized for hardness (Y1), disintegration time (Y2), initial dissolution rate (IDR; Y3) and dissolution efficiency after 30 min (Dissolution Efficiency (DE); Y4). The obtained results showed a significant positive effect of the three independent factors on tablet hardness (P < 0.05), and the interactive effect of Eudragit E 100 and CPV on tablet hardness was significant. Disintegration time was mainly affected by Eudragit E 100 and CPV concentrations. Moreover, IDR was employed to assess the taste masking effect, lower values were obtained at higher Eudragit E 100 concentration despite it was statistically insignificant (p > 0.05). Optimized formulation that was suggested by the software was composed of: Eudragit E 100 (X1) = 2.5% w/w, CPV (X2) = 4.13% w/w, and SSF (X3) = 1.0% w/w. The observed values of the optimized formula were found to be close to the predicted optimized values. The Differential Scanning Calorimetric (DSC) studies indicated no interaction between PMZ and tablet excipients.

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          Lubricants in Pharmaceutical Solid Dosage Forms

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            Advances in drug delivery systems: Work in progress still needed?

            A new era of science and technology has emerged in pharmaceutical research with focus on developing novel drug delivery systems for oral administration. Conventional dosage forms like tablets and capsules are associated with a low bioavailability, frequent application, side effects and hence patient noncompliance. By developing novel strategies for drug delivery, researchers embraced an alternative to traditional drug delivery systems. Out of those, fast dissolving drug delivery systems are very eminent among pediatrics and geriatrics. Orally disintegrating films are superior over fast dissolving tablets as the latter are assigned with the risk of suffocation. Due to their ability of bypassing the dissolution and the first pass effect after oral administration, self-emulsifying formulations have also become increasingly popular in improving oral bioavailability of hydrophobic drugs. Osmotic devices enable a controlled drug delivery independent upon gastrointestinal conditions using osmosis as driving force. The advances in nanotechnology and the variety of possible materials and formulation factors enable a targeted delivery and triggered release. Vesicular systems can be easily modified as required and provide a controlled and sustained drug delivery to a specific site. This work provides an insight of the novel approaches in drug delivery covering the critical comparison between traditional and novel “advanced-designed” systems.
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              Systematic evaluation of common lubricants for optimal use in tablet formulation

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                Author and article information

                Contributors
                Journal
                Saudi Pharm J
                Saudi Pharm J
                Saudi Pharmaceutical Journal : SPJ
                Elsevier
                1319-0164
                2213-7475
                23 April 2021
                May 2021
                23 April 2021
                : 29
                : 5
                : 478-486
                Affiliations
                [a ]Department of Pharmaceutics, College of Pharmacy, Najran University, Najran, Saudi Arabia
                [b ]Kayyali Chair for Pharmaceutical Industries, Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia
                [c ]Department of Pharmaceutics, College of Pharmacy, Al-Azhar University, Assiut, Egypt
                [d ]Department of Applied Pharmaceutical Sciences, Faculty of Pharmacy, Isra University, Amman, Jordan
                Author notes
                [* ]Corresponding author at: Department of Pharmaceutics, College of Pharmacy, Najran University, Najran, Saudi Arabia. hsalmukalas@ 123456nu.edu.sa
                Article
                S1319-0164(21)00068-2
                10.1016/j.jsps.2021.04.011
                8180616
                34135674
                998a5206-0dcb-47c3-9a32-0bfbbf85c6d5
                © 2021 The Author(s)

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                : 23 December 2020
                : 13 April 2021
                Categories
                Original Article

                formulation,promethazine hydrochloride,sublingual,tablet

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