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      A mini-review on drug delivery through wafer technology: Formulation and manufacturing of buccal and oral lyophilizates

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          Highlights

          • This mini-review provides a thorough overview of current buccal/oral lyophilizates.

          • The mini-review discusses material and process parameters using the quality by design (QbD) approach.

          • This study covers trends in experimental buccal/oral formulations.

          • It relates drug and dosage form limitations to aid future developments.

          • It shows buccal/oral lyophilizates as safe and effective prominent drug delivery systems.

          Graphical abstract

          Abstract

          A great number of patients have difficulty swallowing or needle fear. Therefore, buccal and orodispersible dosage forms (ODFs) represent an important strategy to enhance patient compliance. Besides not requiring water intake, swallowing or needles, these dosage forms allow drug release modulation. ODFs include oral lyophilizates or wafers, which present even faster disintegration than its compressed counterparts. Lyophilization can also produce buccal wafers that adhere to mucosa for sustained drug release. Due to the subject relevance and recent research growth, this review focused on oral lyophilizate production technology, formulation features, and therapy gains. It includes Critical Quality Attributes (CQA) and Critical Process Parameters (CPP) and discusses commercial and experimental examples. In sum, the available commercial products promote immediate drug release mainly based on biopolymeric matrixes and two production technologies. Therapy gains include substitution of traditional treatments depending on parenteral administration and patient preference over classical therapies. Experimental wafers show promising advantages as controlled release and drug enhanced stability. All compiled findings encourage the development of new wafers for several diseases and drug molecules.

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          Most cited references53

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          Classification, processing and application of hydrogels: A review.

          This article aims to review the literature concerning the choice of selectivity for hydrogels based on classification, application and processing. Super porous hydrogels (SPHs) and superabsorbent polymers (SAPs) represent an innovative category of recent generation highlighted as an ideal mould system for the study of solution-dependent phenomena. Hydrogels, also termed as smart and/or hungry networks, are currently subject of considerable scientific research due to their potential in hi-tech applications in the biomedical, pharmaceutical, biotechnology, bioseparation, biosensor, agriculture, oil recovery and cosmetics fields. Smart hydrogels display a significant physiochemical change in response to small changes in the surroundings. However, such changes are reversible; therefore, the hydrogels are capable of returning to its initial state after a reaction as soon as the trigger is removed.
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            Insoluble drug delivery strategies: review of recent advances and business prospects

            The emerging trends in the combinatorial chemistry and drug design have led to the development of drug candidates with greater lipophilicity, high molecular weight and poor water solubility. Majority of the failures in new drug development have been attributed to poor water solubility of the drug. Issues associated with poor solubility can lead to low bioavailability resulting in suboptimal drug delivery. About 40% of drugs with market approval and nearly 90% of molecules in the discovery pipeline are poorly water-soluble. With the advent of various insoluble drug delivery technologies, the challenge to formulate poorly water soluble drugs could be achieved. Numerous drugs associated with poor solubility and low bioavailabilities have been formulated into successful drug products. Several marketed drugs were reformulated to improve efficacy, safety and patient compliance. In order to gain marketing exclusivity and patent protection for such products, revitalization of poorly soluble drugs using insoluble drug delivery technologies have been successfully adopted by many pharmaceutical companies. This review covers the recent advances in the field of insoluble drug delivery and business prospects.
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              Pharmaceutical particle technologies: An approach to improve drug solubility, dissolution and bioavailability

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                Author and article information

                Contributors
                Journal
                J Adv Res
                J Adv Res
                Journal of Advanced Research
                Elsevier
                2090-1232
                2090-1224
                03 May 2019
                November 2019
                03 May 2019
                : 20
                : 33-41
                Affiliations
                [a ]Faculty of Pharmaceutical Sciences, University of Campinas, Rua Candido Portinari 200, 13083-871 Campinas, São Paulo, Brazil
                [b ]Institute of Biology, University of Campinas, Rua Monteiro Lobato 255, 13083-970 Campinas, São Paulo, Brazil
                Author notes
                [* ]Corresponding author. lauraon@ 123456unicamp.br
                Article
                S2090-1232(19)30088-8
                10.1016/j.jare.2019.04.010
                6526303
                31193385
                f5ae8fac-a1f3-48e5-a0e2-12c8706718b1
                © 2019 THE AUTHORS. Published by Elsevier BV on behalf of Cairo University.

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

                History
                : 4 December 2018
                : 25 April 2019
                : 26 April 2019
                Categories
                Review Article

                wafer,buccal,lyophilization,freeze-drying,drug delivery,oral lyophilizates

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