Stability of Hydrocortisone in Oral Powder Form Compounded for Pediatric Patients in Japan

Abstract

Hydrocortisone has been utilized in the management of adrenal insufficiency. For pediatric patients, the commercially available enteral form of hydrocortisone tablets (Cortoril®) is administered in powder form after being compounded by a pharmacist. However, the stability and quality of compounded hydrocortisone powder have not been verified. In this study, we formulated a 20 mg/g oral hydrocortisone powder by adding lactose monohydrate to crushed and filtered hydrocortisone tablets and assessed the stability and physical properties of this compounded product in polycarbonate amber bottles or coated paper packages laminated with cellophane and polyethylene. Stability was examined over 120 days in three storage conditions: closed bottle, in-use bottle, and laminated paper. Drug dissolution and powder X-ray diffraction analysis were conducted to assess its physicochemical stabilities. Validated liquid chromatography-diode array detection was used to detect and quantify hydrocortisone and its degradation products. Although impurity B (cortisone) and G (hydrocortisone-21-aldehyde) were found after 120 days of storage, no crystallographic and dissolution changes were noted. Hydrocortisone content was maintained between 90% and 110% of initial contents for 120 days at 25 ± 2 °C and 60 ± 5% relative humidity in all packaging conditions.

Teri Kasalliklarida Qo‘llaniladigan Ayrim Sintetik Dori Vositalarining Kimyoviy Tarkibi Va Xalq Tabobatida Aloe O‘SIMLIGIDAN Foydalanish

“…Oxycort drug contains oxytetracycline hydrochloride 300 mg, hydrocortisone 100 mg [3], sorbitan trioleate -640 mg, lecithin 4.87 mg, isopropyl myristate 5.25 g, propane C3H8, butane C4H10 and isobutane mixture 27 g. Along with the positive effects of this drug, there are also harmful effects. Including local reactions: burning, itching, irritation at the site of application of the drug, drying and atrophy of the skin, rashes, secondary infections.…”

“…preparati tarkibida oksitetratsiklin gidroxloridi 300 mg, gidrokortizon 100 mg[3], sorbitan trioleat -640 mg, lesitin 4.87 mg, izopropil miristat 5.25 g, propan C3H8, butan C4H10 va Journal of Chemistry of Goods and Traditional Medicine, Vol. 2, Iss.…”

Study on the Preparation Method of Quality-Assured In-Hospital Drug Formulation for Children—A Multi-Institutional Collaborative Study

“…The prepared in-hospital pre-products were stored under the following three storage conditions according to the previous study [4][5][6]11]: (1) "Bottle (closed)" condition: stored in polycarbonate bottles (Yamayu, Osaka, Japan), (2) "Bottle (in-use)" condition: 0.1 g weighed daily from the bottle condition, and (3) package condition: packaged in cellophane and polyethylene wrapping paper (TK-70W, Takazono, Tokyo, Japan), and then stored under light-shielded conditions at 25 • C ± 2 • C and 60% ± 5% relative humidity (RH). The samples were stored for 0 to 120 days.…”

“…For drug stability, the samples were obtained from each storage condition at days 0, 30, 60, 90, and 120, diluted according to previously published methods [4][5][6] and analyzed using an HPLC system Ultimate 3000 (Thermo Fisher Scientific, Tokyo, Japan) containing an autosampler, a column oven, and a diode array detector (Table 2). The concentration changes were calculated as (measured concentration/initial concentration) × 100 (%), and within 10% of the initial concentration were considered acceptable changes [12].…”

“…Many in-hospital pre-products often lack quality assurance, such as the assurance of long-term stability and ingredient dissolution. The National Center for Child Health and Development (NCCHD) has been studying the standardization of preparation methods to ensure the quality of in-hospital preparation for pediatric drug therapy, and has examined preparation methods for baclofen, hydrocortisone, and clonidine [4][5][6]. Although the quality of the preparations prepared at the Department of Pharmacy of NCCHD was confirmed to be assured, the quality of products prepared in different environments and by different methods at other facilities is unclear.…”