{"id":"https://openalex.org/W7155494841","doi":"https://doi.org/10.25258/ijddt.16.19s.18","title":"Formulation and Optimization of Fast Mouth Dissolving Tablet of Clozapine Using QbD Approach","display_name":"Formulation and Optimization of Fast Mouth Dissolving Tablet of Clozapine Using QbD Approach","publication_year":2026,"publication_date":"2026-04-24","ids":{"openalex":"https://openalex.org/W7155494841","doi":"https://doi.org/10.25258/ijddt.16.19s.18"},"language":"en","primary_location":{"id":"doi:10.25258/ijddt.16.19s.18","doi":"https://doi.org/10.25258/ijddt.16.19s.18","is_oa":true,"landing_page_url":"https://doi.org/10.25258/ijddt.16.19s.18","pdf_url":"https://doi.org/10.25258/ijddt.16.19s.18","source":{"id":"https://openalex.org/S4210211336","display_name":"International Journal of Drug Delivery Technology","issn_l":"0975-4415","issn":["0975-4415"],"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":["poland-20","russia-white-list-4"],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"International Journal of Drug Delivery Technology","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"bronze","oa_url":"https://doi.org/10.25258/ijddt.16.19s.18","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5134467493","display_name":"Gayatri N. Chaware","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Gayatri N. Chaware","raw_affiliation_strings":["Sandip University, School of Pharmaceutical Sciences, Sandip University, Nashik, (MH)-443201, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Sandip University, School of Pharmaceutical Sciences, Sandip University, Nashik, (MH)-443201, India","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5048945705","display_name":"Ramdas T Dolas","orcid":"https://orcid.org/0000-0002-9744-6230","observed_orcids":["https://orcid.org/0000-0002-9744-6230"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Ramdas T. Dolas","raw_affiliation_strings":["Sandip University, School of Pharmaceutical Sciences, Sandip University, Nashik, (MH)-443201, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Sandip University, School of Pharmaceutical Sciences, Sandip University, Nashik, (MH)-443201, India","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5134531839","display_name":"Hrushikesh M. Suryawanshi","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Hrushikesh M. Suryawanshi","raw_affiliation_strings":["Sandip University, School of Pharmaceutical Sciences, Sandip University, Nashik, (MH)-443201, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Sandip University, School of Pharmaceutical Sciences, Sandip University, Nashik, (MH)-443201, India","institution_ids":[]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5082210843","display_name":"Abhijeet Dattatraya Kulkarni","orcid":"https://orcid.org/0000-0002-9438-7861","observed_orcids":["https://orcid.org/0000-0002-9438-7861"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Abhijeet D. Kulkarni","raw_affiliation_strings":["Sandip University, School of Pharmaceutical Sciences, Sandip University, Nashik, (MH)-443201, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Sandip University, School of Pharmaceutical Sciences, Sandip University, Nashik, (MH)-443201, India","institution_ids":[]}]}],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":0,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":true,"cited_by_count":0,"citation_normalized_percentile":{"value":0.19346319,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":"16","issue":"19s","first_page":null,"last_page":null},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10256","display_name":"Drug Solubulity and Delivery Systems","score":0.9189000129699707,"subfield":{"id":"https://openalex.org/subfields/3003","display_name":"Pharmaceutical Science"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},"topics":[{"id":"https://openalex.org/T10256","display_name":"Drug Solubulity and Delivery Systems","score":0.9189000129699707,"subfield":{"id":"https://openalex.org/subfields/3003","display_name":"Pharmaceutical Science"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T10920","display_name":"Advanced Drug Delivery Systems","score":0.04490000009536743,"subfield":{"id":"https://openalex.org/subfields/3003","display_name":"Pharmaceutical Science"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T12547","display_name":"Pharmaceutical studies and practices","score":0.007499999832361937,"subfield":{"id":"https://openalex.org/subfields/2735","display_name":"Pediatrics, Perinatology and Child Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/clozapine","display_name":"clozapine","score":0.9959999918937683},{"id":"https://openalex.org/keywords/mouth-dissolving-tablets","display_name":"mouth dissolving tablets","score":0.9549999833106995},{"id":"https://openalex.org/keywords/quality-by-design","display_name":"quality by design","score":0.9670000076293945},{"id":"https://openalex.org/keywords/direct-compression","display_name":"direct compression","score":0.6800000071525574},{"id":"https://openalex.org/keywords/superdisintegrants","display_name":"superdisintegrants","score":0.8209999799728394},{"id":"https://openalex.org/keywords/microcrystalline-cellulose","display_name":"microcrystalline cellulose","score":0.9980000257492065},{"id":"https://openalex.org/keywords/crosscarmellose-sodium","display_name":"crosscarmellose sodium","score":0.9150000214576721},{"id":"https://openalex.org/keywords/sodium-stearyl-fumarate","display_name":"sodium stearyl fumarate","score":0.8659999966621399},{"id":"https://openalex.org/keywords/disintegration-time","display_name":"disintegration time","score":0.8199999928474426},{"id":"https://openalex.org/keywords/friability","display_name":"friability","score":0.8119999766349792},{"id":"https://openalex.org/keywords/in-vitro-drug-release","display_name":"in vitro drug release","score":0.9710000157356262},{"id":"https://openalex.org/keywords/factorial-design","display_name":"factorial design","score":0.5920000076293945},{"id":"https://openalex.org/keywords/atypical-antipsychotics","display_name":"atypical antipsychotics","score":0.8119999766349792},{"id":"https://openalex.org/keywords/dysphagia","display_name":"dysphagia","score":0.6579999923706055},{"id":"https://openalex.org/keywords/treatment-adherence","display_name":"medication adherence","score":0.8159999847412109}],"concepts":[{"id":"https://openalex.org/C2779351475","wikidata":"https://www.wikidata.org/wiki/Q417374","display_name":"Microcrystalline cellulose","level":3,"score":0.7063000202178955},{"id":"https://openalex.org/C191168616","wikidata":"https://www.wikidata.org/wiki/Q5503337","display_name":"Friability","level":4,"score":0.5644999742507935},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.5055000185966492},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.5009999871253967},{"id":"https://openalex.org/C77281830","wikidata":"https://www.wikidata.org/wiki/Q718608","display_name":"Dosage form","level":2,"score":0.49889999628067017},{"id":"https://openalex.org/C169222746","wikidata":"https://www.wikidata.org/wiki/Q4116558","display_name":"Factorial experiment","level":2,"score":0.4975000023841858},{"id":"https://openalex.org/C3019981671","wikidata":"https://www.wikidata.org/wiki/Q5165929","display_name":"Immediate release","level":2,"score":0.4471000134944916},{"id":"https://openalex.org/C2780035454","wikidata":"https://www.wikidata.org/wiki/Q8386","display_name":"Drug","level":2,"score":0.4296000003814697},{"id":"https://openalex.org/C136229726","wikidata":"https://www.wikidata.org/wiki/Q327092","display_name":"Biomedical engineering","level":1,"score":0.41179999709129333},{"id":"https://openalex.org/C3019451088","wikidata":"https://www.wikidata.org/wiki/Q67004728","display_name":"Patient compliance","level":2,"score":0.4072999954223633},{"id":"https://openalex.org/C2780864610","wikidata":"https://www.wikidata.org/wiki/Q221361","display_name":"Clozapine","level":3,"score":0.3871000111103058},{"id":"https://openalex.org/C192562407","wikidata":"https://www.wikidata.org/wiki/Q228736","display_name":"Materials science","level":0,"score":0.33079999685287476},{"id":"https://openalex.org/C42404028","wikidata":"https://www.wikidata.org/wiki/Q864940","display_name":"Bioequivalence","level":3,"score":0.32989999651908875},{"id":"https://openalex.org/C46821324","wikidata":"https://www.wikidata.org/wiki/Q7094540","display_name":"Onset of action","level":2,"score":0.3246999979019165},{"id":"https://openalex.org/C2780449318","wikidata":"https://www.wikidata.org/wiki/Q18344773","display_name":"Critical quality attributes","level":3,"score":0.31060001254081726},{"id":"https://openalex.org/C43617362","wikidata":"https://www.wikidata.org/wiki/Q170050","display_name":"Chromatography","level":1,"score":0.29600000381469727},{"id":"https://openalex.org/C2777056448","wikidata":"https://www.wikidata.org/wiki/Q285166","display_name":"Oral administration","level":2,"score":0.28200000524520874},{"id":"https://openalex.org/C88463166","wikidata":"https://www.wikidata.org/wiki/Q1543243","display_name":"Granulation","level":2,"score":0.2759999930858612},{"id":"https://openalex.org/C138651985","wikidata":"https://www.wikidata.org/wiki/Q186249","display_name":"Pharmaceutics","level":2,"score":0.2727000117301941},{"id":"https://openalex.org/C204320433","wikidata":"https://www.wikidata.org/wiki/Q7268772","display_name":"Quality by Design","level":3,"score":0.2703999876976013},{"id":"https://openalex.org/C112497637","wikidata":"https://www.wikidata.org/wiki/Q211669","display_name":"Swallowing","level":2,"score":0.2680000066757202},{"id":"https://openalex.org/C106186310","wikidata":"https://www.wikidata.org/wiki/Q1437823","display_name":"Pharmaceutical formulation","level":2,"score":0.2524000108242035}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.25258/ijddt.16.19s.18","doi":"https://doi.org/10.25258/ijddt.16.19s.18","is_oa":true,"landing_page_url":"https://doi.org/10.25258/ijddt.16.19s.18","pdf_url":"https://doi.org/10.25258/ijddt.16.19s.18","source":{"id":"https://openalex.org/S4210211336","display_name":"International Journal of Drug Delivery Technology","issn_l":"0975-4415","issn":["0975-4415"],"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":["poland-20","russia-white-list-4"],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"International Journal of Drug Delivery Technology","raw_type":"journal-article"}],"best_oa_location":{"id":"doi:10.25258/ijddt.16.19s.18","doi":"https://doi.org/10.25258/ijddt.16.19s.18","is_oa":true,"landing_page_url":"https://doi.org/10.25258/ijddt.16.19s.18","pdf_url":"https://doi.org/10.25258/ijddt.16.19s.18","source":{"id":"https://openalex.org/S4210211336","display_name":"International Journal of Drug Delivery Technology","issn_l":"0975-4415","issn":["0975-4415"],"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":["poland-20","russia-white-list-4"],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"International Journal of Drug Delivery Technology","raw_type":"journal-article"},"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being","score":0.9763000011444092}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":true,"pdf":true},"content_urls":{"pdf":"https://content.openalex.org/works/W7155494841.pdf","grobid_xml":"https://content.openalex.org/works/W7155494841.grobid-xml"},"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W3176088525","https://openalex.org/W2762612150","https://openalex.org/W2001639802","https://openalex.org/W2380026560","https://openalex.org/W7168096411","https://openalex.org/W2594776291","https://openalex.org/W2034954562","https://openalex.org/W158652912","https://openalex.org/W1963487041","https://openalex.org/W4403224247"],"abstract_inverted_index":{"In":[0],"the":[1,14,28,62,69,81,136,148],"current":[2],"investigations,":[3],"mouth":[4],"dissolving":[5],"tablets":[6],"(MDT)":[7],"of":[8,52,71,83,138,162,173,194],"clozapine":[9,74],"were":[10,98,114],"developed":[11,112],"by":[12,16,41],"applying":[13],"quality":[15],"design":[17],"(QbD)":[18],"approach.":[19],"Clozapine,":[20],"an":[21],"atypical":[22],"antipsychotic,":[23],"is":[24,38],"widely":[25],"recognized":[26],"as":[27,92,100,108,120,189],"gold":[29],"standard":[30],"for":[31,68,116,187],"treatmentresistant":[32],"schizophrenia,":[33],"yet":[34],"its":[35],"clinical":[36],"utility":[37],"often":[39],"limited":[40],"poor":[42],"patient":[43,198],"compliance":[44],"due":[45],"to":[46],"swallowing":[47,206],"difficulties":[48],"and":[49,88,96,126,142,153,168,181,200],"delayed":[50],"onset":[51,193],"action":[53],"with":[54,80,205],"conventional":[55],"dosage":[56],"forms.":[57],"To":[58],"address":[59],"these":[60],"challenges,":[61],"direct":[63],"compression":[64],"method":[65],"was":[66,106],"employed":[67],"preparation":[70],"MDT":[72,113],"containing":[73],"using":[75],"a":[76,109,159],"3\u00b2":[77],"factorial":[78],"design,":[79],"quantity":[82],"drug,":[84],"microcrystalline":[85],"cellulose":[86],"(MCC),":[87],"crosscarmellose":[89],"sodium":[90,103],"(CCS)":[91],"dependent":[93],"variables.":[94],"MCC":[95],"CCS":[97],"incorporated":[99],"superdisintegrants,":[101],"while":[102],"stearyl":[104],"fumarate":[105],"used":[107],"lubricant.":[110],"The":[111,155],"evaluated":[115],"critical":[117],"characteristics":[118],"such":[119],"hardness,":[121],"friability,":[122],"disintegration":[123,160,180],"time":[124,161],"(DT),":[125],"in":[127,169,203,210],"vitro":[128,170],"drug":[129,171],"release.":[130],"Design":[131],"Expert":[132],"11.0":[133],"adequately":[134],"described":[135],"impact":[137],"selected":[139],"variables":[140],"(MCC":[141],"CCS)":[143],"at":[144],"various":[145],"levels":[146],"on":[147],"responses":[149],"under":[150],"study":[151],"(DT":[152],"friability).":[154],"optimized":[156],"batch":[157],"demonstrated":[158],"15\u201328":[163],"seconds,":[164],"friability":[165],"within":[166],"1%,":[167],"release":[172,182],"75\u201398%":[174],"after":[175],"30":[176],"minutes.":[177],"Such":[178],"rapid":[179],"profiles":[183],"are":[184],"particularly":[185],"advantageous":[186],"clozapine,":[188],"they":[190],"may":[191],"enhance":[192],"therapeutic":[195],"action,":[196],"improve":[197],"adherence,":[199],"facilitate":[201],"administration":[202],"individuals":[204],"difficulties\u2014a":[207],"common":[208],"concern":[209],"psychiatric":[211],"populations.":[212]},"counts_by_year":[],"updated_date":"2026-10-28T10:33:24.094632","created_date":"2026-04-25T00:00:00"}