{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,18]],"date-time":"2026-03-18T03:00:55Z","timestamp":1773802855086,"version":"3.50.1"},"reference-count":20,"publisher":"The Pediatric Pharmacy Association","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,3,17]]},"abstract":"<jats:sec id=\"st1\">\n                    <jats:title>OBJECTIVE<\/jats:title>\n                    <jats:p>Buprenorphine (BUP) is advantageous in the management of neonatal opioid withdrawal syndrome (NOWS). A widely used BUP formulation for the treatment of NOWS contains 30% ethanol. This study aimed to investigate the stability of BUP in compounded ethanol-free oral syringes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"st2\">\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>A 75-mcg\/mL BUP solution was prepared by diluting the commercial injectable solution with water for irrigation, transferred into amber oral syringes, and stored at either room temperature (n = 3) and refrigerated (n = 3) conditions. Microbial testing of the compounded oral syringes was performed to determine microbial growth for 24 and 48 hours at 37\u00b0C. The stability of BUP was assessed in the compounded syringes was conducted by pH and liquid chromatography-mass spectrometry (LC-MS) analysis after compounding and at 7, 30, and 60 days of storage.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"st3\">\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>The concentration of BUP at all time points was between 90% and 110% of the baseline on day 0. Concentration increased slightly in the oral syringes after day 30, likely due to moisture loss, as there were no degradation peaks observed in chromatograms. There was no microbial growth or visual change observed for the compounded ethanol-free BUP oral syringes. The pH of the oral syringes was consistent through 60 days for both room-temperature and refrigerated samples.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"st4\">\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>Buprenorphine in an ethanol-free formulation is stable and can be easily compounded in pediatric pharmacies. This formulation is appealing for the treatment of NOWS.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.5863\/jppt-25-00058","type":"journal-article","created":{"date-parts":[[2026,3,18]],"date-time":"2026-03-18T01:05:03Z","timestamp":1773795903000},"source":"Crossref","is-referenced-by-count":0,"title":["Stability Study of Compounded Ethanol-Free Buprenorphine Oral Syringes for the Treatment of Neonatal Opioid Withdrawal Syndrome"],"prefix":"10.5863","author":[{"given":"Viren","family":"Soni","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Sciences (VS, SAS, GK), Thomas Jefferson University, Philadelphia, PA"},{"name":"Department of Pharmacology, Physiology & Cancer Biology (VS, WKK), Thomas Jefferson University, Philadelphia, PA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Samarth A.","family":"Shah","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences (VS, SAS, GK), Thomas Jefferson University, Philadelphia, PA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Walter K.","family":"Kraft","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, Physiology & Cancer Biology (VS, WKK), Thomas Jefferson University, Philadelphia, PA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gagan","family":"Kaushal","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences (VS, SAS, GK), Thomas Jefferson University, Philadelphia, PA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"3883","reference":[{"issue":"1","key":"JPPT-25-00058-b01","series-title":"J Pediatr","first-page":"33","article-title":"Standardizing the clinical definition of opioid withdrawal in the neonate","volume":"243","author":"Jilani","year":"2022","unstructured":"Jilani SM, Jones HE, Grossman M, et al. Standardizing the clinical definition of opioid withdrawal in the neonate. J Pediatr. 2022;243(1):33\u201339."},{"issue":"3","key":"JPPT-25-00058-b02","series-title":"J Perinatol","first-page":"300","article-title":"Neonatal opioid withdrawal syndrome: a review of the science and look toward use of buprenorphine for affected infants","volume":"42","author":"Devlin","year":"2022","unstructured":"Devlin LA, Young LW, Kraft WK, et al. Neonatal opioid withdrawal syndrome: a review of the science and look toward use of buprenorphine for affected infants. J Perinatol. 2022;42(3):300\u2013306."},{"issue":"24","key":"JPPT-25-00058-b03","series-title":"N Engl J Med","first-page":"2341","article-title":"Buprenorphine for the treatment of neonatal abstinence syndrome","volume":"376","author":"Kraft","year":"2017","unstructured":"Kraft WK, Adeniyi-Jones SC, Chervoneva I, et al. Buprenorphine for the treatment of neonatal abstinence syndrome. N Engl J Med. 2017;376(24):2341\u20132348."},{"key":"JPPT-25-00058-b04","article-title":"Q2B validation of analytical procedures: methodology. In guidance for industry","unstructured":"US Food and Drug Administration. Q2B validation of analytical procedures: methodology. In guidance for industry. Accessed October 20, 2024. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/q2b-validation-analytical-procedures-methodology"},{"key":"JPPT-25-00058-b05","article-title":"Chapter 791 pH","unstructured":"US Pharmacopeia. Chapter 791 pH. Rockville, MD: The United States Pharmacopeial Convention. Accessed October 20, 2026. https:\/\/doi.usp.org\/USPNF\/USPNF_M99590_02_01.html"},{"issue":"4","key":"JPPT-25-00058-b06","series-title":"J Pediatr Pharmacol Ther","first-page":"395","article-title":"Stability-indicating LC-MS method for determination of stability of extemporaneously compounded buprenorphine oral syringes for neonatal abstinence syndrome","volume":"26","author":"Rochani","year":"2021","unstructured":"Rochani A, Nguyen V, Becker R, et al. Stability-indicating LC-MS method for determination of stability of extemporaneously compounded buprenorphine oral syringes for neonatal abstinence syndrome. J Pediatr Pharmacol Ther. 2021;26(4):395\u2013404."},{"issue":"1","key":"JPPT-25-00058-b07","series-title":"J Pediatr Pharmacol Ther","first-page":"49","article-title":"The bioavailability of CHF6563, an ethanol-free, sublingual neonatal buprenorphine formulation: a bridging study conducted in adults","volume":"29","author":"Kraft","year":"2024","unstructured":"Kraft WK, Barneschi, I, Bocchi M, et al. The bioavailability of CHF6563, an ethanol-free, sublingual neonatal buprenorphine formulation: a bridging study conducted in adults. J Pediatr Pharmacol Ther. 2024;29(1):49\u201352."},{"issue":"12","key":"JPPT-25-00058-b08","series-title":"J Feline Med Surg","first-page":"1035","article-title":"Beyond-use date determination of buprenorphine buccal solution using a stability-indicating high-performance liquid chromatographic assay","volume":"17","author":"Kirk","year":"2015","unstructured":"Kirk LM, Brown SD. Beyond-use date determination of buprenorphine buccal solution using a stability-indicating high-performance liquid chromatographic assay. J Feline Med Surg. 2015;17(12):1035\u20131040."},{"issue":"4","key":"JPPT-25-00058-b09","series-title":"J AM Assoc Lab Anim Sci","first-page":"457","article-title":"Effect of time and storage conditions on the chemical and microbiologic stability of diluted buprenorphine for injection","volume":"56","author":"DenHerder","year":"2017","unstructured":"DenHerder JM, Reed RL, Sargent JL, et al. Effect of time and storage conditions on the chemical and microbiologic stability of diluted buprenorphine for injection. J AM Assoc Lab Anim Sci. 2017;56(4):457\u2013461."},{"issue":"8","key":"JPPT-25-00058-b10","series-title":"J Pediatr Pharmacol Ther","first-page":"710","article-title":"Stability of a compounded sublingual buprenorphine solution for neonatal opioid withdrawal syndrome","volume":"28","author":"Ahmadi","year":"2023","unstructured":"Ahmadi A, Cutaia DR, Perkins JR, et al. Stability of a compounded sublingual buprenorphine solution for neonatal opioid withdrawal syndrome. J Pediatr Pharmacol Ther. 2023;28(8):710\u2013713."},{"issue":"1","key":"JPPT-25-00058-b01","series-title":"J Pediatr","first-page":"33","article-title":"Standardizing the clinical definition of opioid withdrawal in the neonate","volume":"243","author":"Jilani","year":"2022","unstructured":"Jilani SM, Jones HE, Grossman M, et al. Standardizing the clinical definition of opioid withdrawal in the neonate. 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N Engl J Med. 2017;376(24):2341\u20132348."},{"key":"JPPT-25-00058-b04","article-title":"Q2B validation of analytical procedures: methodology. In guidance for industry","unstructured":"US Food and Drug Administration. Q2B validation of analytical procedures: methodology. In guidance for industry. Accessed October 20, 2024. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/q2b-validation-analytical-procedures-methodology"},{"key":"JPPT-25-00058-b05","article-title":"Chapter 791 pH","unstructured":"US Pharmacopeia. Chapter 791 pH. Rockville, MD: The United States Pharmacopeial Convention. Accessed October 20, 2026. https:\/\/doi.usp.org\/USPNF\/USPNF_M99590_02_01.html"},{"issue":"4","key":"JPPT-25-00058-b06","series-title":"J Pediatr Pharmacol Ther","first-page":"395","article-title":"Stability-indicating LC-MS method for determination of stability of extemporaneously compounded buprenorphine oral syringes for neonatal abstinence syndrome","volume":"26","author":"Rochani","year":"2021","unstructured":"Rochani A, Nguyen V, Becker R, et al. Stability-indicating LC-MS method for determination of stability of extemporaneously compounded buprenorphine oral syringes for neonatal abstinence syndrome. J Pediatr Pharmacol Ther. 2021;26(4):395\u2013404."},{"issue":"1","key":"JPPT-25-00058-b07","series-title":"J Pediatr Pharmacol Ther","first-page":"49","article-title":"The bioavailability of CHF6563, an ethanol-free, sublingual neonatal buprenorphine formulation: a bridging study conducted in adults","volume":"29","author":"Kraft","year":"2024","unstructured":"Kraft WK, Barneschi, I, Bocchi M, et al. The bioavailability of CHF6563, an ethanol-free, sublingual neonatal buprenorphine formulation: a bridging study conducted in adults. J Pediatr Pharmacol Ther. 2024;29(1):49\u201352."},{"issue":"12","key":"JPPT-25-00058-b08","series-title":"J Feline Med Surg","first-page":"1035","article-title":"Beyond-use date determination of buprenorphine buccal solution using a stability-indicating high-performance liquid chromatographic assay","volume":"17","author":"Kirk","year":"2015","unstructured":"Kirk LM, Brown SD. Beyond-use date determination of buprenorphine buccal solution using a stability-indicating high-performance liquid chromatographic assay. J Feline Med Surg. 2015;17(12):1035\u20131040."},{"issue":"4","key":"JPPT-25-00058-b09","series-title":"J AM Assoc Lab Anim Sci","first-page":"457","article-title":"Effect of time and storage conditions on the chemical and microbiologic stability of diluted buprenorphine for injection","volume":"56","author":"DenHerder","year":"2017","unstructured":"DenHerder JM, Reed RL, Sargent JL, et al. Effect of time and storage conditions on the chemical and microbiologic stability of diluted buprenorphine for injection. 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