Abstract

Antimicrobial Effectiveness and Physicochemical Stability of Compounded Psychiatric and Neurological Drug Suspensions in SyrSpend® SF PH4

Author(s): Kegele Carolina Schettino, Dijkers Eli, Polonini Hudson

Issue: Jul/Aug 2025 - Volume 29, Number 4

Page(s): 319-327

Download in electronic PDF format for $75
  • Antimicrobial Effectiveness and Physicochemical Stability of Compounded Psychiatric and Neurological Drug Suspensions in SyrSpend® SF PH4 Page 1
  • Antimicrobial Effectiveness and Physicochemical Stability of Compounded Psychiatric and Neurological Drug Suspensions in SyrSpend® SF PH4 Page 2
  • Antimicrobial Effectiveness and Physicochemical Stability of Compounded Psychiatric and Neurological Drug Suspensions in SyrSpend® SF PH4 Page 3
  • Antimicrobial Effectiveness and Physicochemical Stability of Compounded Psychiatric and Neurological Drug Suspensions in SyrSpend® SF PH4 Page 4
  • Antimicrobial Effectiveness and Physicochemical Stability of Compounded Psychiatric and Neurological Drug Suspensions in SyrSpend® SF PH4 Page 5
  • Antimicrobial Effectiveness and Physicochemical Stability of Compounded Psychiatric and Neurological Drug Suspensions in SyrSpend® SF PH4 Page 6
  • Antimicrobial Effectiveness and Physicochemical Stability of Compounded Psychiatric and Neurological Drug Suspensions in SyrSpend® SF PH4 Page 7
  • Antimicrobial Effectiveness and Physicochemical Stability of Compounded Psychiatric and Neurological Drug Suspensions in SyrSpend® SF PH4 Page 8
  • Antimicrobial Effectiveness and Physicochemical Stability of Compounded Psychiatric and Neurological Drug Suspensions in SyrSpend® SF PH4 Page 9

Abstract

Many psychiatric and neurological medications lack commercial liquid formulations, requiring extemporaneous compounding for patients unable to swallow solid dosage forms. While chemical stability data support extended beyond-use dating for various APIs in SyrSpend® SF PH4, antimicrobial effectiveness data essential for USP <795> compliance remain limited. To evaluate antimicrobial effectiveness and physicochemical stability of seven commonly compounded psychiatric and neurological drug suspensions in SyrSpend® SF PH4 to support evidence-based beyond-use dating decisions. Suspensions of amitriptyline hydrochloride (10.0 mg/mL), clonazepam (0.2 mg/mL), haloperidol (0.5 mg/mL), lorazepam (1.0 mg/mL), naltrexone hydrochloride (1.0 mg/mL), pregabalin (20.0 mg/mL), and sertraline hydrochloride (10.0 mg/mL) were prepared and stored at ambient and refrigerated conditions. USP <51> antimicrobial effectiveness testing was conducted alongside pH and visual appearance assessments. All formulations achieved USP <51> bacterial reduction criteria for E. coli, P. aeruginosa, and S. aureus. Complete C. albicans control was demonstrated in all formulations. A. brasiliensis showed variable responses, with persistent counts in naltrexone, pregabalin, and sertraline formulations, though remaining within USP acceptance limits. pH stability was maintained (3.3 - 5.1) with no visual changes observed. Storage temperature did not significantly affect stability. Results support beyond-use dating recommendations for all APIs at all conditions. These evidence-based recommendations provide compounding pharmacists with USP-compliant guidance for safe extended beyond-use dating while maintaining appropriate safety margins for pediatric, geriatric, and other vulnerable populations.

Related Keywords

Related Categories

Printer-Friendly Version

Related Articles from IJPC

Issue/Page
View/Buy
Title/Author
(Click for Abstract / Details / Purchase)
Jul/Aug 2025
Pg. 319-327
Jul/Aug 2025
Pg. 310-318
Mar/Apr 2014
Pg. 123-130
May/Jun 2025
Pg. 222-238
Sep/Oct 2025
Pg. 409-419
Jul/Aug 2020
Pg. 327-336
Mar/Apr 2021
Pg. 169-175
Mar/Apr 2020
Pg. 134
Author(s): Allen Loyd V Jr
Sep/Oct 2015
Pg. 420-427
Sep/Oct 2017
Pg. 356
Author(s): Allen Loyd V Jr
Jan/Feb 2019
Pg. 53
Author(s): Allen Loyd V Jr
Jul/Aug 2013
Pg. 344-346
Nov/Dec 2017
Pg. 491
Author(s): Allen Loyd V Jr
Sep/Oct 2021
Pg. 412
Author(s): Allen Loyd V Jr
Nov/Dec 2021
Pg. 503
Author(s): Allen Loyd V Jr
Mar/Apr 2022
Pg. 140
Author(s): Allen Loyd V Jr
Mar/Apr 2020
Pg. 133
Author(s): Allen Loyd V Jr
Jan/Feb 2020
Pg. 30-36
Author(s): Dillon L R
Jan/Feb 2021
Pg. 46
Author(s): Allen Loyd V Jr
Mar/Apr 2021
Pg. 115-124
Author(s): Kelley Brian