{"id":"https://openalex.org/W7214638697","doi":"https://doi.org/10.3390/ph19101527","title":"A Novel Lorazepam Orodispersible Film: Bioequivalence, Pharmacokinetic, and Tolerability Evaluation Compared with Film-Coated and Orodispersible Tablets in Two Randomized Crossover Studies in Healthy Subjects","display_name":"A Novel Lorazepam Orodispersible Film: Bioequivalence, Pharmacokinetic, and Tolerability Evaluation Compared with Film-Coated and Orodispersible Tablets in Two Randomized Crossover Studies in Healthy Subjects","publication_year":2026,"publication_date":"2026-09-26","ids":{"openalex":"https://openalex.org/W7214638697","doi":"https://doi.org/10.3390/ph19101527","pmid":"https://pubmed.ncbi.nlm.nih.gov/42943224","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/13708311"},"language":"en","primary_location":{"id":"doi:10.3390/ph19101527","doi":"https://doi.org/10.3390/ph19101527","is_oa":true,"landing_page_url":"https://doi.org/10.3390/ph19101527","pdf_url":null,"source":{"id":"https://openalex.org/S16322639","display_name":"Pharmaceuticals","issn_l":"1424-8247","issn":["1424-8247"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","norway-1","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310310987","host_organization_name":"Multidisciplinary Digital Publishing Institute","host_organization_lineage":["https://openalex.org/P4310310987"],"host_organization_lineage_names":["Multidisciplinary Digital Publishing Institute"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Pharmaceuticals","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","doaj","pubmed"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://doi.org/10.3390/ph19101527","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5033185007","display_name":"Valeria Frangione","orcid":"https://orcid.org/0000-0003-0465-8953","observed_orcids":["https://orcid.org/0000-0003-0465-8953"]},"institutions":[{"id":"https://openalex.org/I4210152331","display_name":"IBSA Institut Biochimique (Switzerland)","ror":"https://ror.org/051tj3a26","country_code":"CH","type":"company","lineage":["https://openalex.org/I4210152331"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"Valeria Frangione","raw_affiliation_strings":["IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland"],"raw_orcid":"https://orcid.org/0000-0003-0465-8953","affiliations":[{"raw_affiliation_string":"IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland","institution_ids":["https://openalex.org/I4210152331"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5037525567","display_name":"Cristina Sensi","orcid":"https://orcid.org/0000-0002-3845-3756","observed_orcids":["https://orcid.org/0000-0002-3845-3756"]},"institutions":[{"id":"https://openalex.org/I4210152331","display_name":"IBSA Institut Biochimique (Switzerland)","ror":"https://ror.org/051tj3a26","country_code":"CH","type":"company","lineage":["https://openalex.org/I4210152331"]}],"countries":["CH"],"is_corresponding":true,"raw_author_name":"Cristina Sensi","raw_affiliation_strings":["IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland"],"raw_orcid":"https://orcid.org/0000-0002-3845-3756","affiliations":[{"raw_affiliation_string":"IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland","institution_ids":["https://openalex.org/I4210152331"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5027823359","display_name":"Milko Massimiliano Radicioni","orcid":"https://orcid.org/0000-0002-3940-8375","observed_orcids":["https://orcid.org/0000-0002-3940-8375"]},"institutions":[{"id":"https://openalex.org/I4405267631","display_name":"CROSS Research SA (Switzerland)","ror":"https://ror.org/03nqjwm69","country_code":"CH","type":"company","lineage":["https://openalex.org/I4405267631"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"Milko Massimiliano Radicioni","raw_affiliation_strings":["CROSS Research SA, 6864 Arzo, Switzerland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"CROSS Research SA, 6864 Arzo, Switzerland","institution_ids":["https://openalex.org/I4405267631"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5010635794","display_name":"Fabio Marra","orcid":"https://orcid.org/0000-0002-4194-7925","observed_orcids":["https://orcid.org/0000-0002-4194-7925"]},"institutions":[{"id":"https://openalex.org/I4210125555","display_name":"IBSA Farmaceutici (Italy)","ror":"https://ror.org/02cf8gj49","country_code":"IT","type":"company","lineage":["https://openalex.org/I4210125555"]}],"countries":["IT"],"is_corresponding":false,"raw_author_name":"Fabio Marra","raw_affiliation_strings":["IBSA Farmaceutici Italia, 26900 Lodi, Italy"],"raw_orcid":"https://orcid.org/0000-0002-4194-7925","affiliations":[{"raw_affiliation_string":"IBSA Farmaceutici Italia, 26900 Lodi, Italy","institution_ids":["https://openalex.org/I4210125555"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5017231000","display_name":"Andrea Maria Giori","orcid":"https://orcid.org/0000-0002-3631-5114","observed_orcids":["https://orcid.org/0000-0002-3631-5114"]},"institutions":[{"id":"https://openalex.org/I4210125555","display_name":"IBSA Farmaceutici (Italy)","ror":"https://ror.org/02cf8gj49","country_code":"IT","type":"company","lineage":["https://openalex.org/I4210125555"]}],"countries":["IT"],"is_corresponding":false,"raw_author_name":"Andrea Maria Giori","raw_affiliation_strings":["IBSA Farmaceutici Italia, 26900 Lodi, Italy"],"raw_orcid":"https://orcid.org/0000-0002-3631-5114","affiliations":[{"raw_affiliation_string":"IBSA Farmaceutici Italia, 26900 Lodi, Italy","institution_ids":["https://openalex.org/I4210125555"]}]}],"institutions":[],"countries_distinct_count":2,"institutions_distinct_count":3,"corresponding_author_ids":["https://openalex.org/A5037525567"],"corresponding_institution_ids":["https://openalex.org/I4210152331"],"apc_list":{"value":2900,"currency":"CHF","value_usd":3499},"apc_paid":{"value":2900,"currency":"CHF","value_usd":3499},"fwci":0.0,"has_fulltext":true,"cited_by_count":0,"citation_normalized_percentile":{"value":0.0,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":"19","issue":"10","first_page":"1527","last_page":"1527"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T12547","display_name":"Pharmaceutical studies and practices","score":0.49000000953674316,"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"}},"topics":[{"id":"https://openalex.org/T12547","display_name":"Pharmaceutical studies and practices","score":0.49000000953674316,"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"}},{"id":"https://openalex.org/T10256","display_name":"Drug Solubulity and Delivery Systems","score":0.16359999775886536,"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/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.09700000286102295,"subfield":{"id":"https://openalex.org/subfields/2613","display_name":"Statistics and Probability"},"field":{"id":"https://openalex.org/fields/26","display_name":"Mathematics"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/lorazepam","display_name":"lorazepam","score":1.0},{"id":"https://openalex.org/keywords/orodispersible-films","display_name":"orodispersible films","score":0.9959999918937683},{"id":"https://openalex.org/keywords/bioequivalence","display_name":"bioequivalence","score":0.906000018119812},{"id":"https://openalex.org/keywords/pharmacokinetics","display_name":"pharmacokinetics","score":0.9890000224113464},{"id":"https://openalex.org/keywords/film-coated-tablets","display_name":"film-coated tablets","score":0.9409999847412109},{"id":"https://openalex.org/keywords/orally-disintegrating-tablets","display_name":"orally disintegrating tablets","score":0.9879999756813049},{"id":"https://openalex.org/keywords/benzodiazepines","display_name":"benzodiazepines","score":0.9430000185966492},{"id":"https://openalex.org/keywords/drug-formulation-comparison","display_name":"drug formulation comparison","score":0.6990000009536743},{"id":"https://openalex.org/keywords/tolerability","display_name":"tolerability","score":0.8799999952316284},{"id":"https://openalex.org/keywords/sleepiness","display_name":"sleepiness","score":0.9169999957084656},{"id":"https://openalex.org/keywords/healthy-volunteers","display_name":"healthy volunteers","score":0.5299999713897705}],"concepts":[{"id":"https://openalex.org/C42404028","wikidata":"https://www.wikidata.org/wiki/Q864940","display_name":"Bioequivalence","level":3,"score":0.9463000297546387},{"id":"https://openalex.org/C2778375690","wikidata":"https://www.wikidata.org/wiki/Q7814214","display_name":"Tolerability","level":3,"score":0.8852999806404114},{"id":"https://openalex.org/C2779706987","wikidata":"https://www.wikidata.org/wiki/Q408265","display_name":"Lorazepam","level":2,"score":0.8633999824523926},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.7526999711990356},{"id":"https://openalex.org/C87813604","wikidata":"https://www.wikidata.org/wiki/Q1242899","display_name":"Crossover study","level":4,"score":0.7455999851226807},{"id":"https://openalex.org/C22979827","wikidata":"https://www.wikidata.org/wiki/Q5137311","display_name":"Cmax","level":3,"score":0.7408000230789185},{"id":"https://openalex.org/C112705442","wikidata":"https://www.wikidata.org/wiki/Q323936","display_name":"Pharmacokinetics","level":2,"score":0.7286999821662903},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.5497000217437744},{"id":"https://openalex.org/C181389837","wikidata":"https://www.wikidata.org/wiki/Q461809","display_name":"Bioavailability","level":2,"score":0.5343999862670898},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.5206999778747559},{"id":"https://openalex.org/C42219234","wikidata":"https://www.wikidata.org/wiki/Q131130","display_name":"Anesthesia","level":1,"score":0.4514999985694885},{"id":"https://openalex.org/C2779034229","wikidata":"https://www.wikidata.org/wiki/Q1077823","display_name":"Somnolence","level":3,"score":0.43849998712539673},{"id":"https://openalex.org/C204243189","wikidata":"https://www.wikidata.org/wiki/Q1363085","display_name":"Randomization","level":3,"score":0.3824000060558319},{"id":"https://openalex.org/C111113717","wikidata":"https://www.wikidata.org/wiki/Q725307","display_name":"Pharmacodynamics","level":3,"score":0.3271999955177307},{"id":"https://openalex.org/C2780930544","wikidata":"https://www.wikidata.org/wiki/Q62962","display_name":"Hypnotic","level":2,"score":0.32670000195503235},{"id":"https://openalex.org/C2778173252","wikidata":"https://www.wikidata.org/wiki/Q83871","display_name":"Benzodiazepine","level":3,"score":0.31029999256134033},{"id":"https://openalex.org/C71839028","wikidata":"https://www.wikidata.org/wiki/Q7972627","display_name":"Washout","level":2,"score":0.2996000051498413},{"id":"https://openalex.org/C168563851","wikidata":"https://www.wikidata.org/wiki/Q1436668","display_name":"Randomized controlled trial","level":2,"score":0.29840001463890076},{"id":"https://openalex.org/C77281830","wikidata":"https://www.wikidata.org/wiki/Q718608","display_name":"Dosage form","level":2,"score":0.27730000019073486}],"mesh":[],"locations_count":4,"locations":[{"id":"doi:10.3390/ph19101527","doi":"https://doi.org/10.3390/ph19101527","is_oa":true,"landing_page_url":"https://doi.org/10.3390/ph19101527","pdf_url":null,"source":{"id":"https://openalex.org/S16322639","display_name":"Pharmaceuticals","issn_l":"1424-8247","issn":["1424-8247"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","norway-1","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310310987","host_organization_name":"Multidisciplinary Digital Publishing Institute","host_organization_lineage":["https://openalex.org/P4310310987"],"host_organization_lineage_names":["Multidisciplinary Digital Publishing Institute"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Pharmaceuticals","raw_type":"journal-article"},{"id":"pmh:oai:pubmedcentral.nih.gov:13708311","doi":null,"is_oa":true,"landing_page_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13708311/","pdf_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13708311/pdf/pharmaceuticals-19-01527.pdf","source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Pharmaceuticals (Basel)","raw_type":"Text"},{"id":"pmid:42943224","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/42943224","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Pharmaceuticals (Basel, Switzerland)","raw_type":"Journal Article"},{"id":"pmh:oai:doaj.org/article:6e625120fffc49f59671088eec4079ed","doi":null,"is_oa":false,"landing_page_url":"https://doaj.org/article/6e625120fffc49f59671088eec4079ed","pdf_url":null,"source":{"id":"https://openalex.org/S4306401280","display_name":"DOAJ (DOAJ: Directory of Open Access Journals)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Pharmaceuticals, Vol 19, Iss 10, p 1527 (2026)","raw_type":"article"}],"best_oa_location":{"id":"doi:10.3390/ph19101527","doi":"https://doi.org/10.3390/ph19101527","is_oa":true,"landing_page_url":"https://doi.org/10.3390/ph19101527","pdf_url":null,"source":{"id":"https://openalex.org/S16322639","display_name":"Pharmaceuticals","issn_l":"1424-8247","issn":["1424-8247"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","norway-1","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310310987","host_organization_name":"Multidisciplinary Digital Publishing Institute","host_organization_lineage":["https://openalex.org/P4310310987"],"host_organization_lineage_names":["Multidisciplinary Digital Publishing Institute"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Pharmaceuticals","raw_type":"journal-article"},"sustainable_development_goals":[{"display_name":"Good health and well-being","score":0.9537000060081482,"id":"https://metadata.un.org/sdg/3"}],"study_designs":[{"display_name":"Clinical Trial","id":"https://openalex.org/study-designs/clinical-trial"}],"awards":[],"funders":[],"has_content":{"grobid_xml":true,"pdf":true},"content_urls":{"pdf":"https://content.openalex.org/works/W7214638697.pdf","grobid_xml":"https://content.openalex.org/works/W7214638697.grobid-xml"},"referenced_works_count":36,"referenced_works":["https://openalex.org/W1610957450","https://openalex.org/W1957176172","https://openalex.org/W1980326170","https://openalex.org/W1986403476","https://openalex.org/W1986766832","https://openalex.org/W2002482892","https://openalex.org/W2017507208","https://openalex.org/W2026351952","https://openalex.org/W2034684273","https://openalex.org/W2042182312","https://openalex.org/W2047978949","https://openalex.org/W2069357695","https://openalex.org/W2132518384","https://openalex.org/W2406409796","https://openalex.org/W2580140395","https://openalex.org/W2607212163","https://openalex.org/W2763739906","https://openalex.org/W2801508920","https://openalex.org/W2894695282","https://openalex.org/W2920943188","https://openalex.org/W2992275233","https://openalex.org/W3037627802","https://openalex.org/W3130813498","https://openalex.org/W3159919702","https://openalex.org/W3212918570","https://openalex.org/W4205108637","https://openalex.org/W4291824793","https://openalex.org/W4296830539","https://openalex.org/W4307775467","https://openalex.org/W4385357084","https://openalex.org/W4389547375","https://openalex.org/W4390267830","https://openalex.org/W4391843189","https://openalex.org/W4392543073","https://openalex.org/W4401299032","https://openalex.org/W7117248426"],"related_works":["https://openalex.org/W2327860389","https://openalex.org/W2349501764","https://openalex.org/W4381570593","https://openalex.org/W2363329739","https://openalex.org/W2385992901","https://openalex.org/W2373049937","https://openalex.org/W106309908","https://openalex.org/W2791890856","https://openalex.org/W2410053479","https://openalex.org/W4381164159"],"abstract_inverted_index":{"Introduction:":[0],"Lorazepam":[1,219],"is":[2],"a":[3,79,109,233,241],"widely":[4],"prescribed":[5],"benzodiazepine":[6],"available":[7,54],"in":[8,50,57,70],"multiple":[9],"pharmaceutical":[10],"formulations.":[11],"A":[12,77],"novel":[13],"lorazepam":[14,85,150],"orodispersible":[15,99,229],"film":[16],"(ODF)":[17],"has":[18],"been":[19],"developed":[20],"as":[21,134,240],"an":[22],"alternative":[23,243],"dosage":[24],"form":[25],"designed":[26],"to":[27,225],"address":[28],"administration":[29],"challenges":[30],"and":[31,41,45,98,129,142,160,177,191,197,228],"enhance":[32],"treatment":[33],"adherence.":[34],"Its":[35],"pharmacokinetic":[36,151],"profile,":[37,236],"including":[38],"the":[39,135,163,178,201,213],"rate":[40],"extent":[42],"of":[43,124,137],"absorption,":[44],"its":[46,238],"tolerability":[47,235],"were":[48,68,119,144,169,199,207],"evaluated":[49],"comparison":[51],"with":[52,91,116,157,210,232],"commercially":[53],"oral":[55],"formulations":[56],"two":[58],"bioequivalence":[59,203,224],"studies.":[60],"Methods:":[61],"Two":[62],"single-center,":[63],"single-dose,":[64],"open-label,":[65],"randomized":[66],"studies":[67],"conducted":[69],"healthy":[71],"adults":[72],"under":[73,162],"fasting":[74],"conditions.":[75],"Study":[76,106],"was":[78,108,153,181],"three-way":[80],"crossover":[81,111],"pilot":[82],"study":[83,113],"comparing":[84,114],"2.5":[86,220],"mg":[87,221],"ODF":[88,222],"(test,":[89],"T)":[90],"film-coated":[92,227],"tablets":[93,100],"(Tavor\u00ae,":[94],"reference":[95,103],"1,":[96],"R1)":[97],"(Tavor\u00ae":[101],"ORO,":[102],"2,":[104],"R2).":[105],"B":[107],"two-way":[110],"pivotal":[112],"T":[115,194],"R1.":[117],"Treatments":[118],"separated":[120],"by":[121],"washout":[122],"periods":[123],"\u22657":[125],"days.":[126],"Pharmacokinetic":[127],"parameters":[128],"point":[130],"estimates":[131],"(PEs),":[132],"expressed":[133],"ratios":[136],"least-squares":[138],"geometric":[139],"means":[140],"(T/R1":[141],"T/R2),":[143],"assessed.":[145],"Results:":[146],"In":[147],"both":[148,226],"studies,":[149],"profile":[152],"comparable":[154,234],"across":[155],"formulations,":[156,231],"similar":[158],"Cmax":[159],"area":[161],"curve":[164],"(AUC)":[165],"values.":[166],"Peak":[167],"concentrations":[168],"reached":[170],"within":[171,200],"1\u20131.5":[172],"h":[173],"for":[174,188,193,245],"all":[175],"treatments,":[176],"elimination":[179],"half-life":[180],"approximately":[182],"15\u201316":[183],"h.":[184],"The":[185],"90%":[186],"CIs":[187],"Cmax,":[189],"AUC0\u2013t,":[190],"AUC0\u2013\u221e":[192],"versus":[195],"R1":[196],"R2":[198],"80\u2013125%":[202],"range.":[204],"All":[205],"treatments":[206],"well":[208],"tolerated,":[209],"somnolence":[211],"being":[212],"most":[214],"frequent":[215],"adverse":[216],"event.":[217],"Conclusions:":[218],"demonstrated":[223],"tablet":[230],"supporting":[237],"potential":[239],"convenient":[242],"formulation":[244],"lorazepam.":[246]},"counts_by_year":[],"updated_date":"2026-11-12T12:28:57.059296","created_date":"2026-09-29T00:00:00"}
