Download in electronic PDF format for $25



Search the Complete Journal Archives

Development of Extemporaneously Compounded Aripiprazole Oral Suspensions for Use in Children

Author(s):  Pramann Lance A,Davidow Lawrence W,van Haandel Leon,Funk Ryan S

Issue:  May/Jun 2016 - Volume 20, Number 3
View All Articles in Issue

Abstract:  The purpose of this study was to develop extemporaneously compounded oral liquid formulations of aripiprazole for use in pediatric patients and those patients unable to swallow the solid oral dosage forms. Aripiprazole tablets(30 mg) were ground to a fine powder and suspended at a concentration of 1.0 mg/mL in either a 1:1 blend of Ora-Plus and Ora-Sweet, or 1% methylcellulose and Simple Syrup NF. Five amber, plastic liquid prescription bottles of each formulation were stored at 4°C, and aripiprazole content was measured by ultra-performance liquid chromatography time-of-flight mass spectrometry at 0, 14, 32, 67, and 91 days. Formulations were visually inspected at each time point for color change and precipitation. Forced degradation studies were conducted under oxidizing, acidic, basic, and thermal conditions. Concentrations of aripiprazole in the formulation containing 1:1 Ora-Plus and Ora-Sweet were unchanged over the study period with no signs of degradation over 91 days. In the 1:1 1% methylcellulose and Simple Syrup NF formulation, aripiprazole concentrations were 95% of labeled levels at 67 days, but failed to maintain greater than 90% of labeled levels at 91 days, with an average of only 84% of the labeled content. No apparent physical changes in the formulations were noted over the study period. In the forced degradation studies, loss of aripiprazole was notable under extreme oxidizing and alkaline conditions. Extemporaneously compounded oral suspensions of 1.0 mg/mL aripiprazole in 1:1 Ora-Plus and Ora-Sweet are stable for at least 91 days when stored in amber, plastic prescription bottles at 4°C, whereas suspensions in 1:1 1% methylcellulose and Simple Syrup NF are stable for up to 67 days.

Related Keywords: Lance A. Pramann, Lawrence W. Davidow, PhD, RPh, Leon van Haandel, PhD, Ryan S. Funk, PharmD, PhD, aripiprazole, oral suspension, formulations, children, infants, neuropsychiatric disorders, psychosis, antipsychotic agent, excipients, stability, forced degradation studies

Related Categories: EXCIPIENTS, FORMULATIONS, MENTAL HEALTH, PEDIATRICS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES

Printer-Friendly Version

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Development of Extemporaneously Compounded Aripiprazole Oral Suspensions for Use in Children Pramann Lance A, Davidow Lawrence W, van Haandel Leon, Funk Ryan S May/Jun 2016 257-261 Buy
Wetting and/or Solubilizing Agents, Featured Excipient: Allen Loyd V Jr Jul/Aug 2001 310 Buy
Rapid-Dissolve Technology: An Interview With Loyd V. Allen, Jr., PhD, RPh Allen Loyd V Jr Nov/Dec 2003 449-450 Buy
Physico-chemical Stability of MabThera Drug-product Solution for Subcutaneous Injection under In-use Conditions with Different Administration Materials Mueller Claudia, Dietel Elde, Heynen Severin R, Nalenz Heiko, Goldbach Pierre, Mahler Hanns-Christian, Schmidt Johannes, Grauschopf Ulla, Schoenhammer Karin May/Jun 2015 261-267 Buy
Extended Stability of Morphine and Sildenafil for Oral Use in Infants and Young Children Nahata Milap C May/Jun 2016 247-249 Buy
Stability of Extemporaneously Prepared Hydroxycarbamide Oral Suspensions Kabiche Djamila, Balde Issa-Bella, Majoul Elyes, Kabiche Sofiane, Bourguignon Elodie, Fontan Jean-Eudes, Cisternino Salvatore, Schlatter Joel Mar/Apr 2017 160-163 Buy
Physical and Chemical Stability of Budesonide Mucoadhesive Oral Suspensions (MucoLox) Ip Kendice, Carvalho Maria, Shan Ashley, Banov Daniel Jul/Aug 2017 322-329 Buy
Pediatric Compounding: Coloring Outside the Lines Preckshot John Jan/Feb 2001 6 Buy
Stability Issues for Compounding Extemporaneously Prepared Oral Formulations for Pediatric Patients Schotik Debora Jan/Feb 2001 9 Buy
Aripiprazole 10-mg Oral Dissolving Tablets Allen Loyd V Jr Jan/Feb 2016 49 Buy