title: Formulation and stability of an extemporaneously compounded oral solution of chlorpromazine HCl.
abstract: Chlorpromazine is a phenothiazine antipsychotic which is often used in hospice and palliative care to treat hiccups, delirium, and nausea. With the discontinuation of the commercial oral solution concentrate, there is a need to prepare this product by extemporaneous compounding. This study was initiated to identify an easy-to-prepare formulation for the compounding pharmacist. A stability study was also conducted to select the proper storage conditions and establish the beyond-use date. Chlorpromazine HCl powder and the Ora-Sweet® syrup vehicle were used to prepare the 100 mg/mL solution. Once the feasibility was established, a batch of the solution was prepared and packaged in amber plastic prescription bottles for a stability study. These samples were stored at refrigeration (2-8°C) or room temperature (20-25°C) for up to 3 months. At each monthly time point, the samples were evaluated by visual inspection, pH measurement, and high performance liquid chromatography (HPLC). A separate forced stability study was conducted to confirm that the HPLC method was stability indicating. A clear and colorless solution of 100 mg/mL chlorpromazine HCl was obtained by dissolving the drug powder in Ora-Sweet® with moderate agitation. The stability study results indicated that this solution product remained unchanged in visual appearance or pH at both refrigeration and room temperature for up to 3 months. The HPLC results also confirmed that all stability samples retained 93.6-101.4% of initial drug concentration. Chlorpromazine HCl solution 100 mg/mL can be compounded extemporaneously by dissolving chlorpromazine HCl drug powder in Ora-Sweet®. The resulting product is stable for at least three months in amber plastic prescription bottles stored at either refrigeration or room temperature.
authors.forename: Daniel L
authors.initials: DL
authors.lastname: Prohotsky
authors.forename: Katherine M
authors.initials: KM
authors.lastname: Juba
authors.forename: Fang
authors.initials: F
authors.lastname: Zhao
mesh_terms: D000284:Administration, Oral; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000737:chemistry*; D002746:Chlorpromazine / Q000008:administration & dosage / Q000737:chemistry*; D004339:Drug Compounding / Q000379:methods*; D004355:Drug Stability; D006801:Humans; D019999:Pharmaceutical Solutions / Q000008:administration & dosage / Q000737:chemistry; D013549:Sweetening Agents / Q000008:administration & dosage / Q000737:chemistry
chemical_list: D014150:Antipsychotic Agents; D019999:Pharmaceutical Solutions; D013549:Sweetening Agents; D002746:Chlorpromazine
keywords: buccal; chlorpromazine; compounding; hiccup; intensol; stability; sublingual