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            <front>

                <journal-meta>
                                                                <journal-id>j. res. pharm.</journal-id>
            <journal-title-group>
                                                                                    <journal-title>Journal of Research in Pharmacy</journal-title>
            </journal-title-group>
                                        <issn pub-type="epub">2630-6344</issn>
                                                                                            <publisher>
                    <publisher-name>Marmara University</publisher-name>
                </publisher>
                    </journal-meta>
                <article-meta>
                                        <article-id pub-id-type="doi">10.12991/jrespharm.1798210</article-id>
                                                                <article-categories>
                                            <subj-group  xml:lang="en">
                                                            <subject>Pharmaceutical Sciences</subject>
                                                    </subj-group>
                                            <subj-group  xml:lang="tr">
                                                            <subject>Eczacılık Bilimleri</subject>
                                                    </subj-group>
                                    </article-categories>
                                                                                                                                                        <title-group>
                                                                                                                        <article-title>Design and optimization of prednisolone nanoparticle loaded oral fast dissolving film for mouth ulcers</article-title>
                                                                                                    </title-group>
            
                                                    <contrib-group content-type="authors">
                                                                        <contrib contrib-type="author">
                                                                    <contrib-id contrib-id-type="orcid">
                                        https://orcid.org/0000-0001-6510-0385</contrib-id>
                                                                <name>
                                    <surname>S. Desai</surname>
                                    <given-names>Ujwala</given-names>
                                </name>
                                                                    <aff>Department of Pharmaceutics, Progressive Education Society’s Modern College of Pharmacy, Nigdi, Pune-44, Maharashtra, India.</aff>
                                                            </contrib>
                                                    <contrib contrib-type="author">
                                                                    <contrib-id contrib-id-type="orcid">
                                        https://orcid.org/0000-0002-0813-5554</contrib-id>
                                                                <name>
                                    <surname>D. Chaudhari</surname>
                                    <given-names>Praveen</given-names>
                                </name>
                                                                    <aff>Department of Pharmaceutics, Progressive Education Society’s Modern College of Pharmacy, Nigdi, Pune-44, Maharashtra, India.</aff>
                                                            </contrib>
                                                    <contrib contrib-type="author">
                                                                    <contrib-id contrib-id-type="orcid">
                                        https://orcid.org/0009-0008-2990-5985</contrib-id>
                                                                <name>
                                    <surname>P. Gonde</surname>
                                    <given-names>Dipak</given-names>
                                </name>
                                                                    <aff>Department of Pharmaceutics, Progressive Education Society’s Modern College of Pharmacy, Nigdi, Pune-44, Maharashtra, India.</aff>
                                                            </contrib>
                                                    <contrib contrib-type="author">
                                                                    <contrib-id contrib-id-type="orcid">
                                        https://orcid.org/0009-0000-1740-2426</contrib-id>
                                                                <name>
                                    <surname>N. Bharambe</surname>
                                    <given-names>Sohan</given-names>
                                </name>
                                                                    <aff>Department of Pharmaceutics, Progressive Education Society’s Modern College of Pharmacy, Nigdi, Pune-44, Maharashtra, India.</aff>
                                                            </contrib>
                                                                                </contrib-group>
                        
                                        <pub-date pub-type="pub" iso-8601-date="20251102">
                    <day>11</day>
                    <month>02</month>
                    <year>2025</year>
                </pub-date>
                                        <volume>29</volume>
                                        <issue>6</issue>
                                        <fpage>2542</fpage>
                                        <lpage>2564</lpage>
                        
                        <history>
                                    <date date-type="received" iso-8601-date="20240812">
                        <day>08</day>
                        <month>12</month>
                        <year>2024</year>
                    </date>
                                                    <date date-type="accepted" iso-8601-date="20241114">
                        <day>11</day>
                        <month>14</month>
                        <year>2024</year>
                    </date>
                            </history>
                                        <permissions>
                    <copyright-statement>Copyright © 2010, Journal of Research in Pharmacy</copyright-statement>
                    <copyright-year>2010</copyright-year>
                    <copyright-holder>Journal of Research in Pharmacy</copyright-holder>
                </permissions>
            
                                                                                                <abstract><p>An oral ulcer occurs due to the erosion or loss of the upper mucosal layer, representing one of the mostcommonly encountered pathological conditions within the oral cavity. Typically, these lesions are painful and arepredominantly located on the inner surfaces of the lips and cheeks. Despite their distinct characteristics, all forms ofRecurrent aphthous stomatitis have a significant impact on quality of life and interfere with activities of daily living.Prednisolone Sodium Phosphate [PSP] is a corticosteroid drug used for allergies, inflammatory, autoimmune diseasesand in malignancies. PSP belongs to the Biopharmaceutics Classification System [BCS] class II and exhibits minimalsolubility in water. Therefore, nanotechnology is used for the preparation of formulation which has greater absorptionand bioavailability. The objective of the present research work is to formulate nanoparticles to improve solubility ofPrednisolone Sodium Phosphate [PSP] by using Emulsion- Solvent Evaporation method, and incorporate thesenanoparticles into fast dissolving mouth films for mouth ulcers. Further, we optimized PSP nanoparticles using designof experiments and evaluated optimized prednisolone nanoparticles for Particle Size, Zeta Potential, PolydispersityIndex, Scanning Electron Microscopy and X-Ray Diffraction. The oral fast dissolving films were evaluated on the basisof physical appearance, thickness, pH, weight disintegration time, folding endurance, and stability study. In-vitrodissolution studies demonstrated that more than 80% drug was released from fast- dissolving films. Incorporation ofPSP into nanoparticles resulted in increased solubility of PSP and oral fast dissolving films were utilized as a mediumto transport these nanoparticles for drug delivery applications which have better therapeutic efficiency andbioavailability with significantly higher drug release profile.</p></abstract>
                                                            
            
                                                            <kwd-group>
                                                    <kwd>Nanoparticle</kwd>
                                                    <kwd>  prednisolone sodium phosphate</kwd>
                                                    <kwd>  solubility</kwd>
                                                    <kwd>  oral films</kwd>
                                            </kwd-group>
                            
                                                                                                                        </article-meta>
    </front>
    <back>
                            <ref-list>
                                    <ref id="ref1">
                        <label>1</label>
                        <mixed-citation publication-type="journal">Isher D, Behl A, Singh A, Isher PS, Kaur G, Kaur H. Prevalence of recurrent aphthous ulcers [RAUs] in the population
of Ludhiana. J Indian Acad Oral Med Radiol. 2022; 34(4): 437-441. https://doi.org/10.4103/jiaomr.jiaomr_86_21</mixed-citation>
                    </ref>
                                    <ref id="ref2">
                        <label>2</label>
                        <mixed-citation publication-type="journal">Muñoz-Corcuera M, Esparza-Gómez G, González-Moles MA, Bascones-Martínez A. Oral ulcers: clinical aspects. A
tool for dermatologists. Part I. Acute ulcers. Clin Exp Dermatol. 2009; 34(3): 289–294. https://doi.org/10.1111/j.1365-
2230.2009.03220.x</mixed-citation>
                    </ref>
                                    <ref id="ref3">
                        <label>3</label>
                        <mixed-citation publication-type="journal">Gasmi Benahmed A, Noor S, Menzel A, Gasmi A. Oral Aphthous: Pathophysiology, Clinical Aspects and Medical
Treatment. Arch Razi Inst. 2021; 76(5): 1155-1163. https://doi.org/10.22092/ari.2021.356055.1767</mixed-citation>
                    </ref>
                                    <ref id="ref4">
                        <label>4</label>
                        <mixed-citation publication-type="journal">Altenburg A, El-Haj N, Micheli C, Puttkammer M, Abdel-Naser MB, Zouboulis CC. The treatment of chronic recurrent
oral aphthous ulcers. Dtsch Arztebl Int. 2014; 111(40): 665–673. https://doi.org/10.3238/arztebl.2014.0665</mixed-citation>
                    </ref>
                                    <ref id="ref5">
                        <label>5</label>
                        <mixed-citation publication-type="journal">Scully C, Shotts R. Mouth ulcers and other causes of orofacial soreness and pain. West J Med. 2001; 174(6): 421–424.</mixed-citation>
                    </ref>
                                    <ref id="ref6">
                        <label>6</label>
                        <mixed-citation publication-type="journal">Jinbu Y, Demitsu T. Oral ulcerations due to drug medications. Jpn Dent Sci Rev. 2014; 50(2): 40–46.
https://doi.org/10.1016/j.jdsr.2013.12.001</mixed-citation>
                    </ref>
                                    <ref id="ref7">
                        <label>7</label>
                        <mixed-citation publication-type="journal">Triphati KD, Essentials of Medical Pharmacology, eighth edt. Jay Pee Brothers Medical Publishers, India 2018.</mixed-citation>
                    </ref>
                                    <ref id="ref8">
                        <label>8</label>
                        <mixed-citation publication-type="journal">Chen Y, Liang ZY, Cen YY, Zhang H, Han MG , Tian YQ, Zhang J, Li SJ, Yang DS. Development of oral dispersible
tablets containing prednisolone nanoparticles for the management of pediatric asthma. Drug Des Devel Ther. 2015;9: 5815-5825. https://doi.org/10.2147/DDDT.S86075</mixed-citation>
                    </ref>
                                    <ref id="ref9">
                        <label>9</label>
                        <mixed-citation publication-type="journal">Kumari S, Sarkar L. A Review on Nanoparticles: Structure, Classification, Synthesis &amp; Applications. J Sci Res. 2021;
65(08): 42-46. https://doi.org/10.37398/JSR.2021.650809</mixed-citation>
                    </ref>
                                    <ref id="ref10">
                        <label>10</label>
                        <mixed-citation publication-type="journal">Khan I, Saeed K, Khan I. Nanoparticles: Properties, applications and toxicities.Arab J Chem. 2019; 12(7): 908–931.
https://doi.org/10.1016/j.arabjc.2017.05.011</mixed-citation>
                    </ref>
                                    <ref id="ref11">
                        <label>11</label>
                        <mixed-citation publication-type="journal">Kaur M, Rana AC, Seth N. Fast Dissolving Films: An Innovative Drug Delivery System. Int J Pharm Res. 2013; 2(1):14-
24.</mixed-citation>
                    </ref>
                                    <ref id="ref12">
                        <label>12</label>
                        <mixed-citation publication-type="journal">Brniak W, Maślak E, Jachowicz R. Orodispersible films and tablets with prednisolone microparticles. Eur J Pharm
LL, Sci.2015; 75: 81–90. https://doi.org/10.1016/j.ejps.2015.04.006</mixed-citation>
                    </ref>
                                    <ref id="ref13">
                        <label>13</label>
                        <mixed-citation publication-type="journal">Sankar V, Hearnden V, Hull K, Juras DV, Greenberg MS, Kerr AR, Lockhart PB, Patton Porter S, Thornhill M
Local drug delivery for oral mucosal diseases: challenges and opportunities. Oral Dis. 2011; 17(S1): 73–84.
https://doi.org/10.1111/j.1601-0825.2011.01793.x</mixed-citation>
                    </ref>
                                    <ref id="ref14">
                        <label>14</label>
                        <mixed-citation publication-type="journal">Mahaparale, Wagh BS. Formulation and Evaluation of Mouth Dissolving Film of Glycopyrrolate. Int J
Creat.- Res Thoughts. 2021; 9(9):D509–516.</mixed-citation>
                    </ref>
                                    <ref id="ref15">
                        <label>15</label>
                        <mixed-citation publication-type="journal">Sakhare S, Shinde SD, Venkatrao Yadav A, Somnath Shete A. Studies on formulation and evaluation of Eudragit RS
PO based nanoparticulate system of aceclofenac for ocular delivery. Indian J Pharm Educ Res. 2021; 55(1S): s87–99.
https://doi.org/10.5530/ijper.55.1s.40</mixed-citation>
                    </ref>
                                    <ref id="ref16">
                        <label>16</label>
                        <mixed-citation publication-type="journal">Gill V, Nanda A. Preparation and Characterization of Etodolac Bearing Emulsomes. Int J App Pharm. 2020; 166–172.
https://doi.org/10.22159/ijap.2020v12i5.38842</mixed-citation>
                    </ref>
                                    <ref id="ref17">
                        <label>17</label>
                        <mixed-citation publication-type="journal">Danaei M, Dehghankhold M, Ataei S, Hasanzadeh Davarani F, Javanmard R, Dokhani A, Khorasani S, Mozafari MR.
Impact of Particle Size and Polydispersity Index on the Clinical Applications of Lipidic Nanocarrier Systems.
Pharmaceutics. 2018;10(2):57.https://doi.org/10.3390/pharmaceutics10020057</mixed-citation>
                    </ref>
                                    <ref id="ref18">
                        <label>18</label>
                        <mixed-citation publication-type="journal">Tabassum S, M Ajitha. Quantitative spectrophotometric estimation of prednisolone in tablet dosage form using eco-
friendly green solvent and by applying Beer-Lambert’s Law Mathematical Equation Method. Asian J Res Chem 2021;
14(3): 155–160. https://doi.org/10.52711/0974-4150.2021.00029</mixed-citation>
                    </ref>
                                    <ref id="ref19">
                        <label>19</label>
                        <mixed-citation publication-type="journal">Shareef NB. Direct Determination of Prednisolone by Derivative UV Spectroscopy. Raf J Sci. 2008; 19(3): 38–46.
Shrivastav S, Kaur CD. Development and Validation of Novel UV Spectrophotometric Method for the Determination
oof Mebendazole in Pharmaceutical Formulation. Int J Pharm Sci Res. 2021; 12(4): 2317–2322.</mixed-citation>
                    </ref>
                                    <ref id="ref20">
                        <label>20</label>
                        <mixed-citation publication-type="journal">Verma P, Maheshwari SK. Preparation of Sliver and Selenium Nanoparticles and Its Characterization by Dynamic
Light Scattering and Scanning Electron Microscopy. J Microsc Ultrastruct. 2018; 6(4): 182–187.
https://doi.org/10.4103/JMAU.JMAU_3_18</mixed-citation>
                    </ref>
                                    <ref id="ref21">
                        <label>21</label>
                        <mixed-citation publication-type="journal">Sagadevan S. Analysis of Structure, Surface Morphology, Optical and Electrical Properties of Copper Nanoparticles.
Int J Nanomedicine. 2015; 2(5): 133-136. https://doi.org/10.15406/jnmr.2015.02.00040</mixed-citation>
                    </ref>
                                    <ref id="ref22">
                        <label>22</label>
                        <mixed-citation publication-type="journal">Mourdikoudis S, Pallares RM, Thanh NTK. Characterization techniques for nanoparticles: comparison and
complementarity upon studying nanoparticle properties. Nanoscale. 2018; 10(27): 12871–12934.
https://doi.org/10.1039/C8NR02278J</mixed-citation>
                    </ref>
                                    <ref id="ref23">
                        <label>23</label>
                        <mixed-citation publication-type="journal">Upadhyay S, Parekh K, Pandey B. Influence of crystallite size on the magnetic properties of Fe3O4 nanoparticles. J
Alloys Compds. 2016; 678: 478–485. https://doi.org/10.1016/j.jallcom.2016.03.279</mixed-citation>
                    </ref>
                                    <ref id="ref24">
                        <label>24</label>
                        <mixed-citation publication-type="journal">Sibiya P, Moloto M. Effect of precursor concentration and ph on the shape and size of starch capped silver selenide
[Ag2se] nanoparticles. Chalcogenide Lett. 2014; 11[11]: 577–588. https://chalcogen.ro/577_Sibiya.pdf</mixed-citation>
                    </ref>
                                    <ref id="ref25">
                        <label>25</label>
                        <mixed-citation publication-type="journal">Chaudhari PD, Desai US. Formulation and evaluation of niosomal ın situ gel of prednisolone sodium phosphate for
ocular drug delivery. Int J App Pharm. 2019; 11(2): 97–116. https://doi.org/10.22159/ijap.2019v11i2.30667</mixed-citation>
                    </ref>
                                    <ref id="ref26">
                        <label>26</label>
                        <mixed-citation publication-type="journal">Desai U, Kale S, Alkhaldi H, Manocha V. Aceclofenac solubility enhancement by sono-precipitation method:
formulation optimization, characterization and ın-vitro evaluation. J Adv Sci Res. 2022; 13(09): 33–47.
https://doi.org/10.55218/JASR.202213906</mixed-citation>
                    </ref>
                                    <ref id="ref27">
                        <label>27</label>
                        <mixed-citation publication-type="journal">Lin WJ, Alai M. Application of nanoparticles for oral delivery of acid-labile lansoprazole in the treatment of gastric
ulcer: in vitro and in vivo evaluations. Int J Nanomedicine. 2015; 10(1): 4029-4041.
https://doi.org/10.2147/IJN.S82366</mixed-citation>
                    </ref>
                                    <ref id="ref28">
                        <label>28</label>
                        <mixed-citation publication-type="journal">Garg A, Singh C, Pradhan D, Ghosh G, Rath G. Topical application of nanoparticles integrated supramolecular
hydrogels for the potential treatment of seborrhoeic dermatitis. Pharm Dev Technol. 2020; 25(6): 748–756.
https://doi.org/10.1080/10837450.2020.1740932</mixed-citation>
                    </ref>
                                    <ref id="ref29">
                        <label>29</label>
                        <mixed-citation publication-type="journal">Aparna C, Tejaswini M. Formulation and evaluation of solid lipid nanoparticles of felodipine.Int J Pharm Pharm Res.
2024; 30 (1): 25-41.</mixed-citation>
                    </ref>
                                    <ref id="ref30">
                        <label>30</label>
                        <mixed-citation publication-type="journal">Shelake S, Patil S, Patil SS, Sangave P. Formulation and Evaluation of Fenofibrate-loaded Nanoparticles by
Precipitation Method. Indian J Pharm Sci. 2018; 80(3): 420–427.</mixed-citation>
                    </ref>
                                    <ref id="ref31">
                        <label>31</label>
                        <mixed-citation publication-type="journal">Mudalige T, Qu H, Van Haute D, Ansar SM, Paredes A, Ingle T. Characterization of Nanomaterials: Tools and
Challenges In: Nanomaterials for Food Applications. Elsevier; 2019. pp. 313–53. http://dx.doi.org/10.1016/B978-0-
12-814130-4.00011-7</mixed-citation>
                    </ref>
                                    <ref id="ref32">
                        <label>32</label>
                        <mixed-citation publication-type="journal">Bhutkar KG, Balasubramaniam A, Chamundeeswari V, Radha R. Formulation and evaluation of nanoparticles loaded
with Euphorbia thymifolia extract against experimentally ınduced diabetes. Eur Chem Bull. 2023; 12(6): 2012–2028.
https://www.eurchembull.com/archives/volume-12/issue-5</mixed-citation>
                    </ref>
                                    <ref id="ref33">
                        <label>33</label>
                        <mixed-citation publication-type="journal">Ankita S, Gulab T, Shubhini AS. Formulation and Evaluation of mucoadhesive buccal patch of acyclovir utilizing
inclusion phenomenon. Braz J Pharm Sci 2011; 47(4): 888–897.</mixed-citation>
                    </ref>
                                    <ref id="ref34">
                        <label>34</label>
                        <mixed-citation publication-type="journal">Kulkarni P, Dixit M, Gunashekara K, Shahnawaz A, Singh MN, Kulkarni A. Formulation and evaluation of mouth
dissolving film containing rofecoxib. Int Res J Pharm. 2011; 2(3): 273–278.</mixed-citation>
                    </ref>
                                    <ref id="ref35">
                        <label>35</label>
                        <mixed-citation publication-type="journal">Singh S, Jain S, Muthu MS, Tiwari S, Tilak R. Preparation and evaluation of buccal bioadhesive films containing
clotrimazole. AAPS PharmSciTech. 2008; 9(2): 660–667. https://doi.org/10.1208/s12249-008-9083-3</mixed-citation>
                    </ref>
                                    <ref id="ref36">
                        <label>36</label>
                        <mixed-citation publication-type="journal">Sarfaraz Md, Kumar S, Doddayya H. Fabrication and evaluation of mouth-dissolving films of domperidone. Int J Curr
Pharm Sci. 2023; 15(2): 36–43. https://doi.org/10.22159/ijcpr.2023v15i2.2088</mixed-citation>
                    </ref>
                            </ref-list>
                    </back>
    </article>
