{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T00:45:36Z","timestamp":1792025136387,"version":"4.4.0"},"reference-count":127,"publisher":"Elsevier BV","issue":"7","license":[{"start":{"date-parts":[[2016,7,1]],"date-time":"2016-07-01T00:00:00Z","timestamp":1467331200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2016,7,1]],"date-time":"2016-07-01T00:00:00Z","timestamp":1467331200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"}],"content-domain":{"domain":["jpharmsci.org","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Pharmaceutical Sciences"],"published-print":{"date-parts":[[2016,7]]},"DOI":"10.1016\/j.xphs.2016.03.019","type":"journal-article","created":{"date-parts":[[2016,6,2]],"date-time":"2016-06-02T05:24:37Z","timestamp":1464845077000},"page":"2019-2026","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":144,"title":["An Overview of Pharmaceutical Excipients: Safe or Not Safe?"],"prefix":"10.1016","volume":"105","author":[{"given":"C\u00e1tia G.","family":"Abrantes","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dinah","family":"Duarte","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catarina P.","family":"Reis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"8","key":"10.1016\/j.xphs.2016.03.019_bib1","first-page":"541","article-title":"The safety of pharmaceutical excipients","volume":"58","author":"Pifferi","year":"2003","journal-title":"Farmacognosia"},{"key":"10.1016\/j.xphs.2016.03.019_bib2","first-page":"21","article-title":"Pharmaceutical excipients: a review","volume":"1","author":"Chaudhari","year":"2012","journal-title":"Int J Adv Pharm Biol Chem"},{"key":"10.1016\/j.xphs.2016.03.019_bib3","series-title":"The Nurse Dictionary","author":"Morton","year":"1957"},{"key":"10.1016\/j.xphs.2016.03.019_bib4","series-title":"Dorland\u2019s Medical Dictionary","year":"1974"},{"key":"10.1016\/j.xphs.2016.03.019_bib5","first-page":"59","article-title":"History of excipient safety and toxicity","volume":"103","author":"Winek","year":"2000","journal-title":"Drugs PharmSci"},{"key":"10.1016\/j.xphs.2016.03.019_bib6","first-page":"96","article-title":"Eccipienti ieri e oggi","author":"Pifferi","year":"1996","journal-title":"Rapp GSIRS"},{"key":"10.1016\/j.xphs.2016.03.019_bib7","series-title":"Drugs: From Discovery to Approval","first-page":"480","author":"Ng","year":"2009"},{"issue":"81","key":"10.1016\/j.xphs.2016.03.019_bib8","doi-asserted-by":"crossref","first-page":"181","DOI":"10.1016\/j.ejps.2015.10.016","article-title":"Mitigating unwanted amorphisation: a screening method for the selection of suitable excipients","volume":"1","author":"Amharar","year":"2016","journal-title":"Eur J Pharm Sci"},{"key":"10.1016\/j.xphs.2016.03.019_bib9","doi-asserted-by":"crossref","first-page":"293","DOI":"10.1016\/j.ejpb.2015.04.038","article-title":"Drug delivery\u2019s quest for polymers: where are the frontiers?","volume":"97","author":"Merkle","year":"2015","journal-title":"Eur J Pharm Biopharm"},{"issue":"58","key":"10.1016\/j.xphs.2016.03.019_bib10","doi-asserted-by":"crossref","first-page":"273","DOI":"10.1016\/j.msec.2015.08.031","article-title":"Control-release microcapsule of famotidine loaded biomimetic synthesized mesoporous silica nanoparticles: controlled release effect and enhanced stomach adhesion in\u00a0vitro","volume":"1","author":"Li","year":"2016","journal-title":"Mater Sci Eng C Mater Biol Appl"},{"key":"10.1016\/j.xphs.2016.03.019_bib11","doi-asserted-by":"crossref","first-page":"126","DOI":"10.1016\/j.ejps.2015.11.017","article-title":"Pickering emulsions based on cyclodextrins: a smart solution for antifungal azole derivatives topical delivery","volume":"82","author":"Leclercq","year":"2016","journal-title":"Eur J Pharm Sci"},{"key":"10.1016\/j.xphs.2016.03.019_bib12","doi-asserted-by":"crossref","first-page":"60","DOI":"10.1016\/j.ejps.2015.09.015","article-title":"Encapsulation in a rapid-release liposomal formulation enhances the anti-tumor efficacy of pemetrexed in a murine solid mesothelioma-xenograft model","volume":"81","author":"Eldin","year":"2016","journal-title":"Eur J Pharm Sci"},{"key":"10.1016\/j.xphs.2016.03.019_bib13","first-page":"66","article-title":"Drug-excipient interaction and its importance in dosage form development","volume":"1","author":"Fathima","year":"2011","journal-title":"J\u00a0Appl Pharm Sci"},{"key":"10.1016\/j.xphs.2016.03.019_bib14","doi-asserted-by":"crossref","first-page":"63","DOI":"10.1023\/B:JTAN.0000042154.13588.19","article-title":"Use of isothermal microcalorimetry in pharmaceutical preformulation studies. Part III. Evaluation of excipient compatibility of a new chemical entity","volume":"78","author":"Cavatur","year":"2004","journal-title":"J\u00a0Therm Anal Calorimetry"},{"key":"10.1016\/j.xphs.2016.03.019_bib15","series-title":"Excipient Development for Pharmaceutical, Biotechnology and Drug Delivery Systems","first-page":"93","author":"Moreton","year":"2006"},{"issue":"4","key":"10.1016\/j.xphs.2016.03.019_bib16","doi-asserted-by":"crossref","first-page":"475","DOI":"10.1081\/DDC-120018382","article-title":"Adsorption of an amine drug onto microcrystalline cellulose and silicified microcrystalline cellulose samples","volume":"29","author":"Steele","year":"2003","journal-title":"Drug Dev Ind Pharm"},{"key":"10.1016\/j.xphs.2016.03.019_bib17","doi-asserted-by":"crossref","first-page":"1258","DOI":"10.1023\/A:1016084824877","article-title":"Excipients interaction with Cetylpyridinium chloride activity in tablet based lozenges","volume":"13","author":"Mackay","year":"1996","journal-title":"Pharm Res"},{"key":"10.1016\/j.xphs.2016.03.019_bib18","first-page":"144","article-title":"Solid-state degradation kinetics of nitrazepam in the presence of colloidal silica","volume":"57","author":"Czaja","year":"1982","journal-title":"Pharm Acta Helv"},{"key":"10.1016\/j.xphs.2016.03.019_bib19","doi-asserted-by":"crossref","first-page":"556","DOI":"10.1023\/A:1012136608249","article-title":"Cyclodextrins: their future in drug formulation and delivery","volume":"14","author":"Stella","year":"1997","journal-title":"Pharm Res"},{"key":"10.1016\/j.xphs.2016.03.019_bib20","doi-asserted-by":"crossref","first-page":"69","DOI":"10.1016\/0378-5173(93)90010-D","article-title":"Bioavailability study of tolbutamide \u00df-cyclodextrin inclusion compounds, solid dispersion and bulk powder","volume":"94","author":"Hoffman","year":"1993","journal-title":"Int J Pharm"},{"key":"10.1016\/j.xphs.2016.03.019_bib21","first-page":"63","article-title":"Effect of inert tablet ingredients on drug absorption. I. Effect of polyethylene glycol 4000 on intestinal absorption of four barbiturates","volume":"55","author":"Singh","year":"1996","journal-title":"J\u00a0Pharm Sci"},{"key":"10.1016\/j.xphs.2016.03.019_bib22","first-page":"622","article-title":"Dissolution\u2013dialysis method of assessing in\u00a0vitro drug availability of prednisolone tablets","volume":"30","author":"Northern","year":"1973","journal-title":"Am J Hosp Pharm"},{"key":"10.1016\/j.xphs.2016.03.019_bib23","series-title":"ICH guideline ICHQ3B","first-page":"1","author":"International Conference on Harmonisation","year":"2008"},{"issue":"39","key":"10.1016\/j.xphs.2016.03.019_bib24","doi-asserted-by":"crossref","first-page":"5680","DOI":"10.2174\/1381612821666150901110341","article-title":"Why are excipients important to neonates?","volume":"21","author":"Turner","year":"2015","journal-title":"Curr Pharm Des"},{"issue":"541","key":"10.1016\/j.xphs.2016.03.019_bib25","doi-asserted-by":"crossref","first-page":"1431","DOI":"10.1016\/j.scitotenv.2015.10.029","article-title":"Comparative study of the effect of pharmaceutical additives on the elimination of antibiotic activity during the treatment of oxacillin in water by the photo-Fenton, TiO2-photocatalysis and electrochemical processes","volume":"15","author":"Serna-Galvis","year":"2016","journal-title":"Sci Total Environ"},{"issue":"152","key":"10.1016\/j.xphs.2016.03.019_bib26","doi-asserted-by":"crossref","first-page":"491","DOI":"10.1016\/j.saa.2015.07.101","article-title":"Chemometrics resolution and quantification power evaluation: application on pharmaceutical quaternary mixture of Paracetamol, Guaifenesin, Phenylephrine and p-aminophenol","volume":"5","author":"Yehia","year":"2016","journal-title":"Spectrochim Acta A Mol Biomol Spectrosc"},{"key":"10.1016\/j.xphs.2016.03.019_bib27","article-title":"Addressing specific regulatory excipient requirements in the marketing authorization. IPEC Europe","author":"Hebestreit","year":"2009","journal-title":"PharmSciFair Nice"},{"issue":"1","key":"10.1016\/j.xphs.2016.03.019_bib28","doi-asserted-by":"crossref","first-page":"447","DOI":"10.1016\/j.ijpharm.2015.08.098","article-title":"Advanced qualification of pharmaceutical excipient suppliers by multiple analytics and multivariate analysis combined","volume":"495","author":"Hertrampf","year":"2015","journal-title":"Int J Pharm"},{"key":"10.1016\/j.xphs.2016.03.019_bib29","series-title":"Qualification of excipients for pharmaceutical use","first-page":"55","author":"The International Pharmaceutical Excipients Council","year":"2008"},{"key":"10.1016\/j.xphs.2016.03.019_bib30","series-title":"United States Pharmacopeial Convention","author":"United States Pharmacopeia","year":"1995"},{"key":"10.1016\/j.xphs.2016.03.019_bib31","doi-asserted-by":"crossref","first-page":"206","DOI":"10.1089\/jop.2007.0099","article-title":"An assessment of the ocular safety of inactive excipients following subtenon injection in rabbits","volume":"24","author":"Younis","year":"2008","journal-title":"J\u00a0Ocul Pharmacol Ther"},{"key":"10.1016\/j.xphs.2016.03.019_bib32","series-title":"United States Pharmacopeial Conv","first-page":"1","author":"USP-NF General Notices subsection Ingredients and Processes","year":"2010"},{"key":"10.1016\/j.xphs.2016.03.019_bib33","unstructured":"USP-NF <1078> Good Manufacturing Practices for Bulk Pharmaceutical Excipient. Excipient General Chapters. US Pharmacopeia; p.\u00a02906. Available at: http:\/\/www.pharmacopeia.cn\/v29240\/usp29nf24s0_c1078_viewall.html. Accessed July 17, 2015."},{"key":"10.1016\/j.xphs.2016.03.019_bib34","article-title":"How FDA approves drugs and regulates their safety and effectiveness","author":"Thaul","year":"2012","journal-title":"Congr Res Serv"},{"key":"10.1016\/j.xphs.2016.03.019_bib35","first-page":"177","article-title":"The safety and efficacy of new drug approval","volume":"5","author":"Gieringer","year":"1985","journal-title":"Cato J"},{"key":"10.1016\/j.xphs.2016.03.019_bib36","series-title":"Global regulatory perspective of bulk pharmaceutical excipients","author":"Pramod","year":"2010"},{"key":"10.1016\/j.xphs.2016.03.019_bib37","series-title":"FDA Inventory of GRAS Notifications","author":"Department of Health and Human Services","year":"2004"},{"key":"10.1016\/j.xphs.2016.03.019_bib38","first-page":"13","article-title":"The proposed guidelines for the safety evaluation of new excipients","volume":"2","author":"IPEC Europe Safety Committee","year":"1997","journal-title":"Eur Pharm Rev"},{"key":"10.1016\/j.xphs.2016.03.019_bib39","doi-asserted-by":"crossref","first-page":"149","DOI":"10.1006\/rtph.1996.0120","article-title":"A\u00a0new approach to the safety assessment of pharmaceutical excipients","volume":"24","author":"Steinberg","year":"1996","journal-title":"Regul Toxicol Pharmacol"},{"key":"10.1016\/j.xphs.2016.03.019_bib40","series-title":"Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems","first-page":"127","author":"Ashok","year":"2006"},{"key":"10.1016\/j.xphs.2016.03.019_bib41","unstructured":"S. J. Excipients: Safety Testing. 3rd ed. Encyclopedia of Pharmaceutical Technology. New York, NY: Informa health care; 2007."},{"key":"10.1016\/j.xphs.2016.03.019_bib42","series-title":"Guidance for Industry Nonclinical Studies for\u00a0the Safety Evaluation of Pharmaceutical Excipients. Pharmacology","first-page":"12","author":"Food and Drug Administration","year":"2005"},{"key":"10.1016\/j.xphs.2016.03.019_bib43","first-page":"367","article-title":"Regulating pharmaceuticals in Europe: striving for efficiency, equity and quality","volume":"14","author":"Mossialos","year":"2005","journal-title":"BMJ Qual Saf"},{"key":"10.1016\/j.xphs.2016.03.019_bib44","series-title":"Practice Guide for Bulk Pharmaceutical Excipients","first-page":"1","author":"International Pharmaceutical Excipients Council","year":"1997"},{"key":"10.1016\/j.xphs.2016.03.019_bib45","series-title":"Managing Excipient Testing: Functional and Safety Testing in a Global Marketplace","author":"Grilli","year":"2010"},{"key":"10.1016\/j.xphs.2016.03.019_bib46","series-title":"The Japanese Pharmacopoeia JP XIII 13th Edition","author":"The Society of Japanese Pharmacopoeia","year":"1996"},{"issue":"1","key":"10.1016\/j.xphs.2016.03.019_bib47","first-page":"27","article-title":"Regulatory status of excipients in Japan","volume":"33","author":"Uchiyama","year":"1999","journal-title":"Therapeutic Innovation & Regulatory Science"},{"key":"10.1016\/j.xphs.2016.03.019_bib48","series-title":"ICH Q9: Quality Risk Management","first-page":"23","author":"International Conference on Harmonisation","year":"2006"},{"key":"10.1016\/j.xphs.2016.03.019_bib49","series-title":"The Joint IPEC\u2013PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients","author":"The International Pharmaceutical Excipients Council and Pharmaceutical Quality Group","year":"2006"},{"issue":"3","key":"10.1016\/j.xphs.2016.03.019_bib50","doi-asserted-by":"crossref","first-page":"185","DOI":"10.4103\/0976-500X.162004","article-title":"International conference on harmonization of technical requirements for registration of pharmaceuticals for human use","volume":"6","author":"Singh","year":"2015","journal-title":"J Pharmacol Pharmacother"},{"key":"10.1016\/j.xphs.2016.03.019_bib51","series-title":"Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use","first-page":"14","author":"M4 I","year":"2004"},{"key":"10.1016\/j.xphs.2016.03.019_bib52","unstructured":"Pharmacopeia US. Excipient Biological Safety Evaluation Guidelines [Internet]. Available at: http:\/\/www.pharmacopeia.cn\/v29240\/usp29nf24s0_c1074.html. Accessed July 17, 2015."},{"key":"10.1016\/j.xphs.2016.03.019_bib53","unstructured":"Pharmacopeia US. USP-NF <1225> Validation of Compendial Methods."},{"key":"10.1016\/j.xphs.2016.03.019_bib54","series-title":"Evaluation of Medicines for Human Use: CHMP Assessment Report for Valdoxan-agomelatine. Note Guide Excipients, Antioxidants Antimicrob Preserve Doss Appl Mark Auth a Med Prod [Internet]","author":"Agency EM","year":"2008"},{"key":"10.1016\/j.xphs.2016.03.019_bib55","series-title":"Guideline on the Chemistry of New Active Substances","first-page":"1","author":"The Committee for Medicinal Products for Human Use","year":"2004"},{"key":"10.1016\/j.xphs.2016.03.019_bib56","series-title":"Guideline for Drug Master Files (DMF)","first-page":"1","author":"Federal Drug Administration","year":"2013"},{"key":"10.1016\/j.xphs.2016.03.019_bib57","series-title":"Excipient Master File Guide","author":"IPEC-Americas","year":"2004"},{"key":"10.1016\/j.xphs.2016.03.019_bib58","series-title":"Certificate of Analysis Guide for Bulk Pharmaceutical Excipients","author":"IPEC","year":"2000"},{"key":"10.1016\/j.xphs.2016.03.019_bib59","series-title":"The IPEC Excipient Stability Program Guide","author":"IPEC Europe","year":"2010"},{"key":"10.1016\/j.xphs.2016.03.019_bib60","series-title":"ICH Harmonised Tripartite Guideline Validation of Analytical Procedures: Text and Methodology Q2(R1)","author":"International Committee on Harmonisation","year":"2005"},{"key":"10.1016\/j.xphs.2016.03.019_bib61","series-title":"Q1A(R2) Stability Testing of New Drug Substances and Products","author":"US Department of Health and Human Services. Guidance for Industry","year":"2003"},{"key":"10.1016\/j.xphs.2016.03.019_bib62","unstructured":"IPEC-Americas. Standarized Excipient Information Protocol User Guide. International Pharmaceutical Excipients Council; 2005."},{"key":"10.1016\/j.xphs.2016.03.019_bib63","series-title":"Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7","author":"International Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use","year":"2000"},{"key":"10.1016\/j.xphs.2016.03.019_bib64","series-title":"Good Manufacturing Practices (GMP) for Pharmaceutical Excipients (Vol. 1)","author":"NSF","year":"2011"},{"key":"10.1016\/j.xphs.2016.03.019_bib65","series-title":"Ansel\u2019s Pharmaceutical Dosage Forms and Drug Delivery Systems","first-page":"537","author":"Loyd","year":"2011"},{"key":"10.1016\/j.xphs.2016.03.019_bib66","series-title":"Excipient Performance. 28","first-page":"1","author":"Convention USP","year":"2004"},{"issue":"2","key":"10.1016\/j.xphs.2016.03.019_bib67","doi-asserted-by":"crossref","first-page":"269","DOI":"10.4103\/0250-474X.33155","article-title":"Studies on enhancement of dissolution rate of etoposide","volume":"69","author":"Prasanna Raju","year":"2007","journal-title":"Ind J Pharm Sci"},{"issue":"6","key":"10.1016\/j.xphs.2016.03.019_bib68","first-page":"191","article-title":"Significance of\u00a0pharmaceutical excipients\u2013a review","volume":"2","author":"Raju","year":"2011","journal-title":"J\u00a0Innov Trends Pharm Sci"},{"key":"10.1016\/j.xphs.2016.03.019_bib69","unstructured":"IPEC Europe. International Excipients Certification Project: minimize risks\u2013maximize benefits. 2011:1-2. Available at: http:\/\/www.pqg.org\/download-files\/ExcipCert-4-WhitePaperonExcipientsCertificationFinal.pdf. Accessed May 11, 2016."},{"key":"10.1016\/j.xphs.2016.03.019_bib70","first-page":"6","article-title":"New excipients\u2013from idea to market","volume":"1","author":"Moreton","year":"1998","journal-title":"Am Pharm Rev"},{"key":"10.1016\/j.xphs.2016.03.019_bib71","first-page":"1","article-title":"IPEC-Americans: updated significant change guide for bulk pharmaceutical excipients","author":"Silverstein","year":"2005","journal-title":"Pharm Tech"},{"key":"10.1016\/j.xphs.2016.03.019_bib72","first-page":"52","article-title":"Coprocessed excipients for solid dosage forms","volume":"28","author":"Nachaegari","year":"2004","journal-title":"Pharm Technol"},{"key":"10.1016\/j.xphs.2016.03.019_bib73","series-title":"Handbook of Pharmaceutical Excipients","first-page":"917","author":"Rowe","year":"2009"},{"key":"10.1016\/j.xphs.2016.03.019_bib74","doi-asserted-by":"crossref","first-page":"45","DOI":"10.1016\/j.ejps.2015.11.011","article-title":"Enteric-coated tablet of risedronate sodium in combination with phytic acid, a natural chelating agent, for improved oral bioavailability","volume":"82","author":"Kim","year":"2016","journal-title":"Eur J Pharm Sci"},{"key":"10.1016\/j.xphs.2016.03.019_bib75","doi-asserted-by":"crossref","first-page":"82","DOI":"10.1016\/j.ejps.2015.09.020","article-title":"The potential of immobilized artificial membrane chromatography to predict human oral absorption","volume":"81","author":"Tsopelas","year":"2016","journal-title":"Eur J Pharm Sci"},{"key":"10.1016\/j.xphs.2016.03.019_bib76","series-title":"Guideline on pharmaceutical development of medicines for paediatric use [Internet]","author":"Committee for Medicinal Products for Human Use","year":"2013"},{"key":"10.1016\/j.xphs.2016.03.019_bib77","series-title":"Oral Solutions and Suspensions","author":"Federal Drug Administration","year":"2014"},{"key":"10.1016\/j.xphs.2016.03.019_bib78","doi-asserted-by":"crossref","first-page":"129","DOI":"10.1016\/j.ejps.2015.10.005","article-title":"Development and in\u00a0vitro characterisation of an oral self-emulsifying delivery system for daptomycin","volume":"81","author":"Zupan\u010di\u010d","year":"2016","journal-title":"Eur J Pharm Sci"},{"key":"10.1016\/j.xphs.2016.03.019_bib79","doi-asserted-by":"crossref","first-page":"157","DOI":"10.1016\/j.ejps.2015.10.022","article-title":"In\u00a0vitro characterization of insulin containing thiomeric microparticles as nasal drug delivery system","volume":"81","author":"Deutel","year":"2016","journal-title":"Eur J Pharm Sci"},{"key":"10.1016\/j.xphs.2016.03.019_bib80","doi-asserted-by":"crossref","first-page":"149","DOI":"10.1016\/j.ejps.2015.10.007","article-title":"Mechanochemistry applied to reformulation and scale-up production of Ethionamide: salt selection and solubility enhancement","volume":"81","author":"de Melo","year":"2016","journal-title":"Eur J Pharm Sci"},{"issue":"117","key":"10.1016\/j.xphs.2016.03.019_bib81","doi-asserted-by":"crossref","first-page":"210","DOI":"10.1016\/j.jpba.2015.08.019","article-title":"Comparative evaluation of the effect of cyclodextrins and pH on aqueous solubility of apigenin","volume":"5","author":"P\u00e1pay","year":"2016","journal-title":"J\u00a0Pharm Biomed Anal"},{"issue":"12","key":"10.1016\/j.xphs.2016.03.019_bib82","doi-asserted-by":"crossref","first-page":"21549","DOI":"10.3390\/molecules201219777","article-title":"Determination of solubility parameters of ibuprofen and ibuprofen Lysinate","volume":"20","author":"Kitak","year":"2015","journal-title":"Molecules"},{"key":"10.1016\/j.xphs.2016.03.019_bib83","first-page":"73","article-title":"Preparation and evaluation of taste masked oral suspension of arbidol hydrochloride","volume":"10","author":"Wang","year":"2015","journal-title":"Asian J Pharm Sci"},{"issue":"2","key":"10.1016\/j.xphs.2016.03.019_bib84","doi-asserted-by":"crossref","first-page":"201","DOI":"10.1023\/B:PHAM.0000016235.32639.23","article-title":"Solubilizing excipients in oral and injectable formulations","volume":"21","author":"Strickley","year":"2004","journal-title":"Pharm Res"},{"issue":"11","key":"10.1016\/j.xphs.2016.03.019_bib85","doi-asserted-by":"crossref","first-page":"4955","DOI":"10.1002\/jps.21354","article-title":"Chitin-silicon dioxide coprecipitate as a novel superdisintegrant","volume":"97","author":"Rashid","year":"2008","journal-title":"J\u00a0Pharm Sci"},{"issue":"2","key":"10.1016\/j.xphs.2016.03.019_bib86","first-page":"213","article-title":"Excipients and delivery systems for pharmaceutical formulation","volume":"66","author":"Buckton","year":"1995","journal-title":"R\u00a0Soc Chem"},{"key":"10.1016\/j.xphs.2016.03.019_bib87","series-title":"Bioadhesion Possibilities and Future Trends","first-page":"22","author":"Veillard","year":"1989"},{"key":"10.1016\/j.xphs.2016.03.019_bib88","first-page":"1","article-title":"Excipient functionality","volume":"35","author":"Moreton","year":"2011","journal-title":"Pharm Tech"},{"key":"10.1016\/j.xphs.2016.03.019_bib89","doi-asserted-by":"crossref","first-page":"18","DOI":"10.1016\/j.ejps.2015.09.018","article-title":"Soluble \u03b2-(1,3)-glucans enhance LPS-induced response in the monocyte activation test, but inhibit LPS-mediated febrile response in rabbits: implications for pyrogenicity tests","volume":"81","author":"Pardo-Ruiz","year":"2016","journal-title":"Eur J Pharm Sci"},{"issue":"3","key":"10.1016\/j.xphs.2016.03.019_bib90","first-page":"3","article-title":"Interactions and incompatibilities of pharmaceutical excipients with active pharmaceutical ingredients: a comprehensive review","volume":"1","author":"Bharate","year":"2010","journal-title":"J\u00a0Excipients Food Chem"},{"key":"10.1016\/j.xphs.2016.03.019_bib91","doi-asserted-by":"crossref","first-page":"1359","DOI":"10.1002\/jps.2600581112","article-title":"Pharmaceutical heterogeneous systems IV: a kinetic approach to the stability screening of solid dosage forms containing aspirin","volume":"58","author":"Maulding","year":"1969","journal-title":"J\u00a0Pharm Sci"},{"key":"10.1016\/j.xphs.2016.03.019_bib92","doi-asserted-by":"crossref","first-page":"104","DOI":"10.1023\/A:1016458701059","article-title":"Water vapor sorption of water-soluble substances: studies of crystalline solids below their critical relative humidities","volume":"4","author":"Kontny","year":"1987","journal-title":"Pharm Res"},{"key":"10.1016\/j.xphs.2016.03.019_bib93","doi-asserted-by":"crossref","first-page":"355","DOI":"10.3109\/03639048209022105","article-title":"Equilibrium moisture content of pharmaceutical excipients","volume":"8","author":"Callahan","year":"1982","journal-title":"Drug Dev Ind Pharm"},{"key":"10.1016\/j.xphs.2016.03.019_bib94","first-page":"125","article-title":"Water vapor sorption by pharmaceutical sugars","volume":"1","author":"Hancock","year":"1999","journal-title":"Pharm Sci Technol"},{"key":"10.1016\/j.xphs.2016.03.019_bib95","doi-asserted-by":"crossref","first-page":"303","DOI":"10.1081\/PDT-100100545","article-title":"Influence of peroxide impurities in povidone and crospovidone on the stability of raloxifene hydrochloride in tablets: identification and control of an oxidative degradation product","volume":"5","author":"Hartauer","year":"2000","journal-title":"Pharm Dev Technol"},{"key":"10.1016\/j.xphs.2016.03.019_bib96","doi-asserted-by":"crossref","first-page":"754","DOI":"10.1021\/pr800858h","article-title":"A\u00a0perspective on the Maillard reaction and the analysis of protein glycation by mass spectrometry: probing the pathogenesis of chronic disease","volume":"2","author":"Zhang","year":"2009","journal-title":"J\u00a0Proteome Res"},{"issue":"3","key":"10.1016\/j.xphs.2016.03.019_bib97","first-page":"172","article-title":"Degradation of glucose in the presence of\u00a0electrolytes during heat sterilization","volume":"40","author":"Buxton","year":"1994","journal-title":"Eur J Pharm Biopharm"},{"key":"10.1016\/j.xphs.2016.03.019_bib98","doi-asserted-by":"crossref","first-page":"115","DOI":"10.1016\/S0169-409X(01)00102-8","article-title":"Chemical reactivity in solid-state pharmaceuticals: formulation implications","volume":"48","author":"Byrn","year":"2001","journal-title":"Adv Drug Deliv Rev"},{"key":"10.1016\/j.xphs.2016.03.019_bib99","doi-asserted-by":"crossref","first-page":"336","DOI":"10.1016\/S1461-5347(00)00301-1","article-title":"Drug\u2013excipient interactions and their affect on absorption","volume":"3","author":"Jackson","year":"2000","journal-title":"Pharm Sci Technol Today"},{"issue":"13","key":"10.1016\/j.xphs.2016.03.019_bib100","doi-asserted-by":"crossref","first-page":"2115","DOI":"10.3109\/03639048909052523","article-title":"Whither compatibility testing?","volume":"15","author":"Monkhouse","year":"1989","journal-title":"Drug Dev Ind Pharm"},{"issue":"5","key":"10.1016\/j.xphs.2016.03.019_bib101","doi-asserted-by":"crossref","first-page":"797","DOI":"10.1111\/1523-1747.ep12292244","article-title":"Photo-enhanced modification of human skin elastin in actinic elastosis by N-(carboxymethyl)lysine, one of the glycoxidation products of the Maillard reaction","volume":"108","author":"Mizutari","year":"1997","journal-title":"J\u00a0Invest Dermatol"},{"issue":"6","key":"10.1016\/j.xphs.2016.03.019_bib102","doi-asserted-by":"crossref","first-page":"237","DOI":"10.1016\/S1461-5347(99)00158-3","article-title":"Excipients as stabilizers","volume":"2","author":"Crowley","year":"1999","journal-title":"Pharm Sci Technol"},{"issue":"3","key":"10.1016\/j.xphs.2016.03.019_bib103","doi-asserted-by":"crossref","first-page":"243","DOI":"10.3109\/10837459709031444","article-title":"Use of chitosan in compressed tablets of diclofenac sodium: inhibition of drug release in an acidic environment","volume":"2","author":"Sabnis","year":"1997","journal-title":"Pharm Dev Technol"},{"issue":"1","key":"10.1016\/j.xphs.2016.03.019_bib104","doi-asserted-by":"crossref","first-page":"31","DOI":"10.1021\/js9702067","article-title":"Maillard reaction of lactose and fluoxetine hydrochloride, a secondary amine","volume":"87","author":"Wirth","year":"1998","journal-title":"J\u00a0Pharm Sci"},{"issue":"5","key":"10.1016\/j.xphs.2016.03.019_bib105","first-page":"320","volume":"42","author":"Tischinger-Wagner","year":"1987","journal-title":"Pharmazie"},{"issue":"3","key":"10.1016\/j.xphs.2016.03.019_bib106","first-page":"173","article-title":"The grinding of the polymorphic forms of chloramphenicol stearic ester in the presence of colloidal silica","volume":"25","author":"Forni","year":"1988","journal-title":"Acta Pharm Suec"},{"issue":"8","key":"10.1016\/j.xphs.2016.03.019_bib107","doi-asserted-by":"crossref","first-page":"311","DOI":"10.1016\/S1461-5347(99)00181-9","article-title":"Differential scanning calorimetry: applications in drug development","volume":"2","author":"Clas","year":"1999","journal-title":"Pharm Sci Technol"},{"issue":"6","key":"10.1016\/j.xphs.2016.03.019_bib108","doi-asserted-by":"crossref","first-page":"262","DOI":"10.1016\/S1461-5347(98)00066-2","article-title":"Contribution of thermal methods and related techniques to the rational development of pharmaceuticals\u2013Part 2","volume":"1","author":"Giron","year":"1998","journal-title":"Pharm Sci Technol"},{"issue":"2","key":"10.1016\/j.xphs.2016.03.019_bib109","doi-asserted-by":"crossref","first-page":"119","DOI":"10.1081\/PDT-120018476","article-title":"A\u00a0new approach to accelerated drug-excipient compatibility testing","volume":"8","author":"Sims","year":"2003","journal-title":"Pharm Dev Technol"},{"issue":"10","key":"10.1016\/j.xphs.2016.03.019_bib110","doi-asserted-by":"crossref","first-page":"943","DOI":"10.1080\/03639040500306153","article-title":"Compatibility studies between ibuprofen or ketoprofen with cellulose ether polymer mixtures using thermal analysis","volume":"31","author":"Vueba","year":"2005","journal-title":"Drug Dev Ind Pharm"},{"issue":"3","key":"10.1016\/j.xphs.2016.03.019_bib111","doi-asserted-by":"crossref","first-page":"449","DOI":"10.1016\/j.jpba.2004.01.012","article-title":"Compatibility studies between isosorbide mononitrate and selected excipients used in the development of extended release formulations","volume":"35","author":"Verma","year":"2004","journal-title":"J\u00a0Pharm Biomed Anal"},{"issue":"1","key":"10.1016\/j.xphs.2016.03.019_bib112","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1016\/S1461-5347(99)00227-8","article-title":"Application of isothermal microcalorimetry in solid state drug development","volume":"3","author":"Phipps","year":"2000","journal-title":"Pharm Sci Technol"},{"issue":"1-2","key":"10.1016\/j.xphs.2016.03.019_bib113","doi-asserted-by":"crossref","first-page":"151","DOI":"10.1016\/S0731-7085(98)00171-X","article-title":"Compatibility study between ibuproxam and pharmaceutical excipients using differential scanning calorimetry, hot-stage microscopy and scanning electron microscopy","volume":"18","author":"Mura","year":"1998","journal-title":"J\u00a0Pharm Biomed Anal"},{"key":"10.1016\/j.xphs.2016.03.019_bib114","series-title":"ICH Harmonised Tripartite Guideline Impurities: Guideline for Residual Solvents Q3C(R5)","first-page":"1","author":"International Conference on Harmonisation","year":"2005"},{"key":"10.1016\/j.xphs.2016.03.019_bib115","series-title":"Impurities in New Drug Products Q3B(R2)","author":"International Conference on Harmonisation","year":"2006"},{"key":"10.1016\/j.xphs.2016.03.019_bib116","doi-asserted-by":"crossref","first-page":"21","DOI":"10.1016\/j.ejps.2015.11.007","article-title":"Evaluation of physicochemical properties and in\u00a0vivo efficiency of atorvastatin calcium\/ezetimibe solid dispersions","volume":"82","author":"Jahangiri","year":"2016","journal-title":"Eur J Pharm Sci"},{"issue":"1","key":"10.1016\/j.xphs.2016.03.019_bib117","first-page":"38","volume":"10","author":"Lesney","year":"2001","journal-title":"More than just the sugar in the pill, Today\u2019s Chemist at Work"},{"issue":"10","key":"10.1016\/j.xphs.2016.03.019_bib118","first-page":"500","article-title":"Drug impurities: problems and regulations","volume":"138","author":"Pifferi","year":"1999","journal-title":"Boll Chim Farm"},{"key":"10.1016\/j.xphs.2016.03.019_bib119","series-title":"Drugs and Pharmaceutical Sciences","first-page":"21","article-title":"Excipient toxicity and safety","author":"Weiner","year":"1999"},{"key":"10.1016\/j.xphs.2016.03.019_bib120","series-title":"La Sicurezza Degli Eccipienti","first-page":"9","author":"Pifferi","year":"2001"},{"issue":"12","key":"10.1016\/j.xphs.2016.03.019_bib121","first-page":"26","article-title":"Aspects relating to excipient quality and specifications","volume":"11","author":"Moreton","year":"1999","journal-title":"Pharm Technol Eur"},{"key":"10.1016\/j.xphs.2016.03.019_bib122","first-page":"50","article-title":"Good Manufacturing Practices: supplementary guidelines for the manufacture of pharmaceutical excipients","volume":"885","year":"1999","journal-title":"World Health Organ Tech Rep Ser"},{"key":"10.1016\/j.xphs.2016.03.019_bib123","first-page":"21","article-title":"Good distribution practice\u2013a new challenge to improve excipient safety","author":"IPEC Europe","year":"2000","journal-title":"Pharm Techn Eur"},{"key":"10.1016\/j.xphs.2016.03.019_bib124","first-page":"925","article-title":"Compatibilit\u00e0 chimico-fisica tra tiocolchicoside e farmaci antinfiammatori non steroidei","volume":"132","author":"Pifferi","year":"1993","journal-title":"Boll Chim Farm"},{"issue":"2","key":"10.1016\/j.xphs.2016.03.019_bib125","first-page":"115","article-title":"Metabisulfite sensitivity: case report and literature review","volume":"54","author":"Jamieson","year":"1985","journal-title":"Ann Allergy"},{"issue":"12","key":"10.1016\/j.xphs.2016.03.019_bib126","first-page":"1449","article-title":"Excipients and additives: hidden hazards in drug products and in product substitution","volume":"131","author":"Napke","year":"1984","journal-title":"Can Med Assoc J"},{"issue":"1","key":"10.1016\/j.xphs.2016.03.019_bib127","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1016\/j.jsps.2013.06.003","article-title":"Importance and globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients","volume":"23","author":"Abdellah","year":"2013","journal-title":"Saudi Pharm J"}],"container-title":["Journal of Pharmaceutical Sciences"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0022354916004470?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0022354916004470?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,3,10]],"date-time":"2026-03-10T21:19:32Z","timestamp":1773177572000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0022354916004470"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,7]]},"references-count":127,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2016,7]]}},"alternative-id":["S0022354916004470"],"URL":"https:\/\/doi.org\/10.1016\/j.xphs.2016.03.019","relation":{},"ISSN":["0022-3549"],"issn-type":[{"value":"0022-3549","type":"print"}],"subject":[],"published":{"date-parts":[[2016,7]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"An Overview of Pharmaceutical Excipients: Safe or Not Safe?","name":"articletitle","label":"Article Title"},{"value":"Journal of Pharmaceutical Sciences","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.xphs.2016.03.019","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2016 American Pharmacists Association\u00ae. Published by Elsevier Inc. All rights reserved.","name":"copyright","label":"Copyright"}]}}