{"id":"https://openalex.org/W2677528802","doi":"https://doi.org/10.1016/j.ijpharm.2017.06.054","title":"Retrospective Quality by Design (rQbD) applied to the optimization of orodispersible films","display_name":"Retrospective Quality by Design (rQbD) applied to the optimization of orodispersible films","publication_year":2017,"publication_date":"2017-06-19","ids":{"openalex":"https://openalex.org/W2677528802","doi":"https://doi.org/10.1016/j.ijpharm.2017.06.054","mag":"2677528802","pmid":"https://pubmed.ncbi.nlm.nih.gov/28629981"},"language":"en","primary_location":{"id":"doi:10.1016/j.ijpharm.2017.06.054","doi":"https://doi.org/10.1016/j.ijpharm.2017.06.054","is_oa":false,"landing_page_url":"https://doi.org/10.1016/j.ijpharm.2017.06.054","pdf_url":null,"source":{"id":"https://openalex.org/S131016564","display_name":"International Journal of Pharmaceutics","issn_l":"0378-5173","issn":["0378-5173","1873-3476"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-d","doyens","jufo-2","ki-jl-2","medline","norway-2","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"International Journal of Pharmaceutics","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","pubmed"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5005975846","display_name":"Branca M. A. Silva","orcid":"https://orcid.org/0000-0002-5529-6174","observed_orcids":["https://orcid.org/0000-0002-5529-6174"]},"institutions":[{"id":"https://openalex.org/I4405255317","display_name":"Bluepharma (Portugal)","ror":"https://ror.org/02vxrsd04","country_code":"PT","type":"company","lineage":["https://openalex.org/I4405255317"]},{"id":"https://openalex.org/I76903346","display_name":"University of Coimbra","ror":"https://ror.org/04z8k9a98","country_code":"PT","type":"education","lineage":["https://openalex.org/I76903346"]}],"countries":["PT"],"is_corresponding":true,"raw_author_name":"Branca M.A. Silva","raw_affiliation_strings":["Bluepharma-Ind\u00fastria Farmac\u00eautica, S.A., S\u00e3o Martinho do Bispo, 3045-016 Coimbra, Portugal; Faculty of Pharmacy, University of Coimbra, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal. Electronic address: branca.silva@bluepharmagroup.com","Bluepharma-Ind\u00fastria Farmac\u00eautica, S.A., S\u00e3o Martinho do Bispo, 3045-016 Coimbra, Portugal","Faculty of Pharmacy, University of Coimbra, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Bluepharma-Ind\u00fastria Farmac\u00eautica, S.A., S\u00e3o Martinho do Bispo, 3045-016 Coimbra, Portugal; Faculty of Pharmacy, University of Coimbra, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal. Electronic address: branca.silva@bluepharmagroup.com","institution_ids":["https://openalex.org/I4405255317","https://openalex.org/I76903346"]},{"raw_affiliation_string":"Bluepharma-Ind\u00fastria Farmac\u00eautica, S.A., S\u00e3o Martinho do Bispo, 3045-016 Coimbra, Portugal","institution_ids":["https://openalex.org/I4405255317"]},{"raw_affiliation_string":"Faculty of Pharmacy, University of Coimbra, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal","institution_ids":["https://openalex.org/I76903346"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5103757489","display_name":"S\u00edlvia Vicente","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4405255317","display_name":"Bluepharma (Portugal)","ror":"https://ror.org/02vxrsd04","country_code":"PT","type":"company","lineage":["https://openalex.org/I4405255317"]}],"countries":["PT"],"is_corresponding":false,"raw_author_name":"S\u00edlvia Vicente","raw_affiliation_strings":["Bluepharma-Ind\u00fastria Farmac\u00eautica, S.A., S\u00e3o Martinho do Bispo, 3045-016 Coimbra, Portugal"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Bluepharma-Ind\u00fastria Farmac\u00eautica, S.A., S\u00e3o Martinho do Bispo, 3045-016 Coimbra, Portugal","institution_ids":["https://openalex.org/I4405255317"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5055960633","display_name":"Sofia Cunha","orcid":"https://orcid.org/0000-0001-7113-3108","observed_orcids":["https://orcid.org/0000-0001-7113-3108"]},"institutions":[{"id":"https://openalex.org/I4405255317","display_name":"Bluepharma (Portugal)","ror":"https://ror.org/02vxrsd04","country_code":"PT","type":"company","lineage":["https://openalex.org/I4405255317"]}],"countries":["PT"],"is_corresponding":false,"raw_author_name":"Sofia Cunha","raw_affiliation_strings":["Bluepharma-Ind\u00fastria Farmac\u00eautica, S.A., S\u00e3o Martinho do Bispo, 3045-016 Coimbra, Portugal"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Bluepharma-Ind\u00fastria Farmac\u00eautica, S.A., S\u00e3o Martinho do Bispo, 3045-016 Coimbra, Portugal","institution_ids":["https://openalex.org/I4405255317"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5013963430","display_name":"Jorge F. J. Coelho","orcid":"https://orcid.org/0000-0001-9351-1704","observed_orcids":["https://orcid.org/0000-0001-9351-1704"]},"institutions":[{"id":"https://openalex.org/I76903346","display_name":"University of Coimbra","ror":"https://ror.org/04z8k9a98","country_code":"PT","type":"education","lineage":["https://openalex.org/I76903346"]}],"countries":["PT"],"is_corresponding":false,"raw_author_name":"Jorge F.J. Coelho","raw_affiliation_strings":["CEMMPRE, Department of Chemical Engineering, University of Coimbra, Polo II, Rua S\u00edlvio Lima, 3030-790 Coimbra, Portugal"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"CEMMPRE, Department of Chemical Engineering, University of Coimbra, Polo II, Rua S\u00edlvio Lima, 3030-790 Coimbra, Portugal","institution_ids":["https://openalex.org/I76903346"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5100627134","display_name":"Cl\u00e1udia Silva","orcid":"https://orcid.org/0000-0003-1664-7768","observed_orcids":["https://orcid.org/0000-0003-1664-7768"]},"institutions":[{"id":"https://openalex.org/I4405255317","display_name":"Bluepharma (Portugal)","ror":"https://ror.org/02vxrsd04","country_code":"PT","type":"company","lineage":["https://openalex.org/I4405255317"]}],"countries":["PT"],"is_corresponding":false,"raw_author_name":"Cl\u00e1udia Silva","raw_affiliation_strings":["Bluepharma-Ind\u00fastria Farmac\u00eautica, S.A., S\u00e3o Martinho do Bispo, 3045-016 Coimbra, Portugal"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Bluepharma-Ind\u00fastria Farmac\u00eautica, S.A., S\u00e3o Martinho do Bispo, 3045-016 Coimbra, Portugal","institution_ids":["https://openalex.org/I4405255317"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5006529383","display_name":"Marco S. Reis","orcid":"https://orcid.org/0000-0002-4997-8865","observed_orcids":["https://orcid.org/0000-0002-4997-8865"]},"institutions":[{"id":"https://openalex.org/I76903346","display_name":"University of Coimbra","ror":"https://ror.org/04z8k9a98","country_code":"PT","type":"education","lineage":["https://openalex.org/I76903346"]}],"countries":["PT"],"is_corresponding":false,"raw_author_name":"Marco Seabra Reis","raw_affiliation_strings":["CIEPQPF, Department of Chemical Engineering, University of Coimbra, Polo II, Rua S\u00edlvio Lima, 3030-790 Coimbra, Portugal"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"CIEPQPF, Department of Chemical Engineering, University of Coimbra, Polo II, Rua S\u00edlvio Lima, 3030-790 Coimbra, Portugal","institution_ids":["https://openalex.org/I76903346"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5064456553","display_name":"S\u00e9rgio Sim\u00f5es","orcid":"https://orcid.org/0000-0002-8898-7625","observed_orcids":["https://orcid.org/0000-0002-8898-7625"]},"institutions":[{"id":"https://openalex.org/I4405255317","display_name":"Bluepharma (Portugal)","ror":"https://ror.org/02vxrsd04","country_code":"PT","type":"company","lineage":["https://openalex.org/I4405255317"]},{"id":"https://openalex.org/I76903346","display_name":"University of Coimbra","ror":"https://ror.org/04z8k9a98","country_code":"PT","type":"education","lineage":["https://openalex.org/I76903346"]}],"countries":["PT"],"is_corresponding":false,"raw_author_name":"S\u00e9rgio Sim\u00f5es","raw_affiliation_strings":["Bluepharma-Ind\u00fastria Farmac\u00eautica, S.A., S\u00e3o Martinho do Bispo, 3045-016 Coimbra, Portugal; Faculty of Pharmacy, University of Coimbra, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal","Bluepharma-Ind\u00fastria Farmac\u00eautica, S.A., S\u00e3o Martinho do Bispo, 3045-016 Coimbra, Portugal","Faculty of Pharmacy, University of Coimbra, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Bluepharma-Ind\u00fastria Farmac\u00eautica, S.A., S\u00e3o Martinho do Bispo, 3045-016 Coimbra, Portugal; Faculty of Pharmacy, University of Coimbra, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal","institution_ids":["https://openalex.org/I4405255317","https://openalex.org/I76903346"]},{"raw_affiliation_string":"Bluepharma-Ind\u00fastria Farmac\u00eautica, S.A., S\u00e3o Martinho do Bispo, 3045-016 Coimbra, Portugal","institution_ids":["https://openalex.org/I4405255317"]},{"raw_affiliation_string":"Faculty of Pharmacy, University of Coimbra, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal","institution_ids":["https://openalex.org/I76903346"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":2,"corresponding_author_ids":["https://openalex.org/A5005975846"],"corresponding_institution_ids":["https://openalex.org/I4405255317","https://openalex.org/I76903346"],"apc_list":{"value":4650,"currency":"USD","value_usd":4650},"apc_paid":null,"fwci":1.3673,"has_fulltext":false,"cited_by_count":29,"citation_normalized_percentile":{"value":0.81887313,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":88,"max":99},"biblio":{"volume":"528","issue":"1-2","first_page":"655","last_page":"663"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11798","display_name":"Optimal Experimental Design Methods","score":0.22130000591278076,"subfield":{"id":"https://openalex.org/subfields/1803","display_name":"Management Science and Operations Research"},"field":{"id":"https://openalex.org/fields/18","display_name":"Decision Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},"topics":[{"id":"https://openalex.org/T11798","display_name":"Optimal Experimental Design Methods","score":0.22130000591278076,"subfield":{"id":"https://openalex.org/subfields/1803","display_name":"Management Science and Operations Research"},"field":{"id":"https://openalex.org/fields/18","display_name":"Decision Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T12547","display_name":"Pharmaceutical studies and practices","score":0.1996999979019165,"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/T10920","display_name":"Advanced Drug Delivery Systems","score":0.18479999899864197,"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"}}],"keywords":[{"id":"https://openalex.org/keywords/orodispersible-films","display_name":"orodispersible films","score":0.9940000176429749},{"id":"https://openalex.org/keywords/residual-moisture-content","display_name":"residual moisture","score":0.9309999942779541},{"id":"https://openalex.org/keywords/design-space","display_name":"design space","score":0.6610000133514404},{"id":"https://openalex.org/keywords/risk-assessment","display_name":"risk assessment","score":0.703000009059906},{"id":"https://openalex.org/keywords/critical-quality-attributes","display_name":"critical quality attributes","score":0.7889999747276306},{"id":"https://openalex.org/keywords/storage-stability","display_name":"storage stability","score":0.6000000238418579},{"id":"https://openalex.org/keywords/drying-temperature","display_name":"drying temperature","score":0.8640000224113464},{"id":"https://openalex.org/keywords/relative-humidity","display_name":"relative humidity","score":0.8840000033378601},{"id":"https://openalex.org/keywords/room-temperature","display_name":"room temperature","score":0.6819999814033508},{"id":"https://openalex.org/keywords/historical-process-data","display_name":"historical process data","score":0.5009999871253967},{"id":"https://openalex.org/keywords/statistical-modeling","display_name":"statistical modeling","score":0.5419999957084656}],"concepts":[{"id":"https://openalex.org/C2779530757","wikidata":"https://www.wikidata.org/wiki/Q1207505","display_name":"Quality (philosophy)","level":2,"score":0.5092183351516724},{"id":"https://openalex.org/C204320433","wikidata":"https://www.wikidata.org/wiki/Q7268772","display_name":"Quality by Design","level":3,"score":0.4629095494747162},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.45432865619659424},{"id":"https://openalex.org/C2984430287","wikidata":"https://www.wikidata.org/wiki/Q186249","display_name":"Pharmaceutical technology","level":2,"score":0.4518841505050659},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.341869980096817},{"id":"https://openalex.org/C21880701","wikidata":"https://www.wikidata.org/wiki/Q2144042","display_name":"Process engineering","level":1,"score":0.3321060538291931},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.3193112313747406},{"id":"https://openalex.org/C185592680","wikidata":"https://www.wikidata.org/wiki/Q2329","display_name":"Chemistry","level":0,"score":0.27992942929267883},{"id":"https://openalex.org/C21547014","wikidata":"https://www.wikidata.org/wiki/Q1423657","display_name":"Operations management","level":1,"score":0.19004735350608826},{"id":"https://openalex.org/C43617362","wikidata":"https://www.wikidata.org/wiki/Q170050","display_name":"Chromatography","level":1,"score":0.17180433869361877},{"id":"https://openalex.org/C138885662","wikidata":"https://www.wikidata.org/wiki/Q5891","display_name":"Philosophy","level":0,"score":0.12546321749687195},{"id":"https://openalex.org/C111472728","wikidata":"https://www.wikidata.org/wiki/Q9471","display_name":"Epistemology","level":1,"score":0.087921142578125},{"id":"https://openalex.org/C2776207758","wikidata":"https://www.wikidata.org/wiki/Q5303302","display_name":"Downstream (manufacturing)","level":2,"score":0.0}],"mesh":[{"descriptor_ui":"D000284","descriptor_name":"Administration, Oral","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D002626","descriptor_name":"Chemistry, Pharmaceutical","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D003890","descriptor_name":"Desiccation","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004304","descriptor_name":"Dosage Forms","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D013678","descriptor_name":"Technology, Pharmaceutical","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D013696","descriptor_name":"Temperature","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014867","descriptor_name":"Water","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D015195","descriptor_name":"Drug Design","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true}],"locations_count":2,"locations":[{"id":"doi:10.1016/j.ijpharm.2017.06.054","doi":"https://doi.org/10.1016/j.ijpharm.2017.06.054","is_oa":false,"landing_page_url":"https://doi.org/10.1016/j.ijpharm.2017.06.054","pdf_url":null,"source":{"id":"https://openalex.org/S131016564","display_name":"International Journal of Pharmaceutics","issn_l":"0378-5173","issn":["0378-5173","1873-3476"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-d","doyens","jufo-2","ki-jl-2","medline","norway-2","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"International Journal of Pharmaceutics","raw_type":"journal-article"},{"id":"pmid:28629981","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/28629981","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":"International journal of pharmaceutics","raw_type":"Journal Article"}],"best_oa_location":null,"sustainable_development_goals":[],"study_designs":[],"awards":[],"funders":[{"id":"https://openalex.org/F4320334779","display_name":"Funda\u00e7\u00e3o para a Ci\u00eancia e a Tecnologia","ror":"https://ror.org/00snfqn58"}],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":22,"referenced_works":["https://openalex.org/W1275656638","https://openalex.org/W1850584827","https://openalex.org/W1964482978","https://openalex.org/W1974949465","https://openalex.org/W1974975763","https://openalex.org/W1997187492","https://openalex.org/W2024926723","https://openalex.org/W2039721926","https://openalex.org/W2047667390","https://openalex.org/W2055939992","https://openalex.org/W2077256124","https://openalex.org/W2077285487","https://openalex.org/W2085045578","https://openalex.org/W2088482441","https://openalex.org/W2113531769","https://openalex.org/W2326167548","https://openalex.org/W2462718095","https://openalex.org/W2480937959","https://openalex.org/W2490341650","https://openalex.org/W2506104693","https://openalex.org/W2591776947","https://openalex.org/W3004335124"],"related_works":["https://openalex.org/W2887955218","https://openalex.org/W2088482441","https://openalex.org/W4295154860","https://openalex.org/W2617650134","https://openalex.org/W3039394195","https://openalex.org/W4405713791","https://openalex.org/W4292260875","https://openalex.org/W4225405834","https://openalex.org/W3128024144","https://openalex.org/W4399177972"],"abstract_inverted_index":null,"counts_by_year":[{"year":2026,"cited_by_count":2},{"year":2025,"cited_by_count":2},{"year":2024,"cited_by_count":3},{"year":2023,"cited_by_count":8},{"year":2022,"cited_by_count":5},{"year":2021,"cited_by_count":3},{"year":2020,"cited_by_count":3},{"year":2019,"cited_by_count":2},{"year":2018,"cited_by_count":1}],"updated_date":"2026-11-07T11:25:07.637180","created_date":"2017-06-30T00:00:00"}