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      Self‐microemulsifying oral fast dissolving films of vitamin D3 for infants: Preparation and characterization

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          Abstract

          Combining the advantages of self‐microemulsifying technology and oral fast dissolving technology, a self‐microemulsifying oral fast dissolving films (SMEOFDF) of vitamin D3 was developed in this study. The pseudoternary phase diagram of microemulsion was constructed using water titration method, and the formulation of films was optimized by orthogonal experimental design. The prepared SMEOFDF of vitamin D3 was a thin film, in which the liquid drops of self‐microemulsion were embedded. It had good mechanical properties (thickness 166.7 ± 3.30 µm, tensile strength 38.45 ± 3.72 MPa, elongation 23.38 ± 4.23%, and folding endurance >200 times), and its disintegration time was about 18 ± 1.23 s. After being redissolved in water, microemulsion could form spontaneously, with particle size of 181.2 nm and zeta potential of 16.1 mV. The release profile of vitamin D from SMEOFDF could be well described by first‐order equation.

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          Prevention of rickets and vitamin D deficiency in infants, children, and adolescents.

          Rickets in infants attributable to inadequate vitamin D intake and decreased exposure to sunlight continues to be reported in the United States. There are also concerns for vitamin D deficiency in older children and adolescents. Because there are limited natural dietary sources of vitamin D and adequate sunshine exposure for the cutaneous synthesis of vitamin D is not easily determined for a given individual and may increase the risk of skin cancer, the recommendations to ensure adequate vitamin D status have been revised to include all infants, including those who are exclusively breastfed and older children and adolescents. It is now recommended that all infants and children, including adolescents, have a minimum daily intake of 400 IU of vitamin D beginning soon after birth. The current recommendation replaces the previous recommendation of a minimum daily intake of 200 IU/day of vitamin D supplementation beginning in the first 2 months after birth and continuing through adolescence. These revised guidelines for vitamin D intake for healthy infants, children, and adolescents are based on evidence from new clinical trials and the historical precedence of safely giving 400 IU of vitamin D per day in the pediatric and adolescent population. New evidence supports a potential role for vitamin D in maintaining innate immunity and preventing diseases such as diabetes and cancer. The new data may eventually refine what constitutes vitamin D sufficiency or deficiency.
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            Age-appropriate and acceptable paediatric dosage forms: Insights into end-user perceptions, preferences and practices from the Children's Acceptability of Oral Formulations (CALF) Study.

            A lack of evidence to guide the design of age-appropriate and acceptable dosage forms has been a longstanding knowledge gap in paediatric formulation development. The Children's Acceptability of Oral Formulations (CALF) study captured end-user perceptions and practices with a focus on solid oral dosage forms, namely tablets, capsules, chewables, orodispersibles, multiparticulates (administered with food) and mini-tablets (administered directly into the mouth). A rigorous development and testing phase produced age-adapted questionnaires as measurement tools with strong evidence of validity and reliability. Overall, 590 school children and adolescents, and 428 adult caregivers were surveyed across hospitals and various community settings. Attitudes towards dosage forms primarily differed based on age and prior use. Positive attitudes to tablets and capsules increased with age until around 14 years. Preference was seen for chewable and orodispersible preparations across ages, while multiparticulates were seemingly less favourable. Overall, 59.6% of school children reported willingness to take 10mm diameter tablets, although only 32.1% of caregivers perceived this size to be suitable. While not to be taken as prescriptive guidance, the results of this study provide some evidence towards rational dosage form design, as well as methodological approaches to help design tools for further evaluation of acceptability within paediatric studies.
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              Ropivacaine loaded microemulsion and microemulsion-based gel for transdermal delivery: Preparation, optimization, and evaluation

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                Author and article information

                Contributors
                khliu@shou.edu.cn
                Journal
                Food Sci Nutr
                Food Sci Nutr
                10.1002/(ISSN)2048-7177
                FSN3
                Food Science & Nutrition
                John Wiley and Sons Inc. (Hoboken )
                2048-7177
                11 July 2019
                August 2019
                : 7
                : 8 ( doiID: 10.1002/fsn3.v7.8 )
                : 2577-2583
                Affiliations
                [ 1 ] College of Food Science and Technology Shanghai Ocean University Shanghai China
                [ 2 ] National Experimental Teaching Demonstration Center for Food Science and Engineering Shanghai Ocean University Shanghai China
                Author notes
                [*] [* ] Correspondence

                Kehai Liu, College of Food Science and Technology, Shanghai Ocean University, Shanghai 201306, China.

                Email: khliu@ 123456shou.edu.cn

                Author information
                https://orcid.org/0000-0002-7213-0918
                https://orcid.org/0000-0003-2505-5553
                Article
                FSN31108
                10.1002/fsn3.1108
                6694412
                5b60d747-9ada-49b1-a2e2-4ad9ed566f10
                © 2019 The Authors. Food Science & Nutrition published by Wiley Periodicals, Inc.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                : 07 January 2019
                : 09 May 2019
                Page count
                Figures: 3, Tables: 5, Pages: 7, Words: 4915
                Funding
                Funded by: Leading Academic Discipline Project of Shanghai Municipal Education Commission
                Award ID: J50704
                Categories
                Original Research
                Original Research
                Custom metadata
                2.0
                fsn31108
                August 2019
                Converter:WILEY_ML3GV2_TO_NLMPMC version:5.6.7 mode:remove_FC converted:15.08.2019

                infant,oral fast dissolving films,release kinetics,self‐microemulsifying,vitamin d

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