Download in electronic PDF format for $25

Kalchem International - Chemicals and Compounding Supplies

Search the Complete Journal Archives

Physical and Chemical Stability of Budesonide Mucoadhesive Oral Suspensions (MucoLox)

Author(s):  Ip Kendice,Carvalho Maria,Shan Ashley,Banov Daniel

Issue:  Jul/Aug 2017 - Volume 21, Number 4
View All Articles in Issue

Abstract:  Budesonide is a corticosteroid that has been shown effective in the treatment of eosinophilic esophagitis, but there are currently no commercial medicines to treat this chronic allergic/immune condition, despite its prevalence in the U.S. Therefore, pharmaceutical compounding is the alternative choice to meet the therapeutic need of eosinophilic esophagitis patients. Two budesonide mucoadhesive oral suspensions (1 mg/10 mL and 2 mg/10 mL) were developed using the compounding vehicle MucoLox, a proprietary mucoadhesive polymer blend that promotes mucosal adhesion. The physical and chemical stability of the oral suspensions was tested over a period of 182 days, at room temperature and refrigerated conditions, in order to determine the corresponding beyond-use date. The physical characterization consisted in observing all samples for color/appearance and odor, and testing for pH and density, whereas the chemical characterization consisted in ultra-performance liquid chromatography assay testing. Both oral suspensions were proven physically and chemically stable, and the ultra-performance liquid chromatography method was proven stability indicating. As a result, the beyond-use date of the budesonide 1-mg/10-mL and 2-mg/10-mL mucoadhesive oral suspensions (MucoLox), in amber plastic bottles, is six months at both room temperature and refrigerated conditions.

Related Keywords: Kendice Ip, BA, Maria Carvalho, PharmD, MRPharmS, PhD, Ashley Shan, Daniel Banov, MS, budesonide, corticosteroid, asthma, inflammatory bowel disease, eosinophilic esophagitis, mucoadhesive oral suspensions, mucosal adhesion, anti-inflammatory agent, formulation, physical stability, chemical stability, forced degradation studies, stability-indicating assay, storage

Related Categories: EXCIPIENTS, FORMULATIONS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, ALLERGY/IMMUNOLOGY/INFLAMMATION, STORAGE

Printer-Friendly Version

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/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
Pluronic Lecithin Organogel for Local Delivery of Anti-Inflammatory Drugs Frankum James, Ramsay Dale, Das Nandita G, Das Sudip K Mar/Apr 2004 101 Buy
Utilization of Compounded Medications in an Oral Medicine Practice Stock Shannon, Rubino Katie, Woo Sook-Bon, Margolis Arthur, Thomas Irena, Aboalela Ali, Treister Nathaniel Mar/Apr 2016 155-158 Buy
Eosinophilic Esophagitis: Treatment with Oral Viscous Budesonide Zur Eyal Jul/Aug 2012 288-293 Buy
Management of Psoriasis with a XemaTop Topical Compounded Formula: A Case Report Jones Nat, Carvalho Maria, Branvold-Herr Andrea May/Jun 2017 205-211 Buy
The Treatment of Canine Atopic Disease Davidson Gigi S May/Jun 2002 210-215 Buy
Wetting and/or Solubilizing Agents, Featured Excipient: Allen Loyd V Jr Jul/Aug 2001 310 Buy
Basics of Compounding for Raynaud's Disease Glasnapp Andrew Jul/Aug 2003 288 Buy
Case Report: Diabetic Foot Ulcer Infection Treated with Topical Compounded Medications Agbi Kelechi E, Carvalho Maria, Phan Ha, Tuma Cristiane Jan/Feb 2017 22-27 Buy
Enhancement of Skin Penetration of Nonsteroidal Anti-Inflammatory Drugs from Extemporaneously Compounded Topical-Gel Formulations Goodwin Donald A, Fuhram L Clifton Nov/Dec 1999 496-500 Buy