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  • [Preparation of dealcholized onetaxotere®, docetaxel injection formulation and its pharmacokinetics in rats].

[Preparation of dealcholized onetaxotere®, docetaxel injection formulation and its pharmacokinetics in rats].

Gan to kagaku ryoho. Cancer & chemotherapy (2013-07-19)
Katsuhiro Onishi, Ikuto Tsukiyama, Miki Katoh, Jun Ueyama, Fumie Abe, Hiroko Saito, Katsuhiko Matsuura, Takaaki Hasegawa, Masayuki Nadai
PMID23863730
ABSTRACT

Onetaxotere®(OTAX)injection, which is a docetaxel(DOC)injection formulation, cannot be administered to those patients with alcohol intolerance or hypersensitivity, because it contains ethanol as a dissolving agent. To broaden treatment options for those patients, we tried to eliminate ethanol from OTAX injection. Under sterile conditions, dealcoholization was carried out using nitrogen gas in a hot water bath at 50°C. By this method, the ethanol included in OTAX injection was almost completely removed and DOC in the formulation was stable for 28 days. When the dealcoholized or untreated OTAX injection was intravenously injected in rats, no significant differences in the pharmacokinetic parameters of DOC were observed between those with dealcoholized and untreated OTAX injections. It is expected that dealcoholized OTAX may be useful in patients with alcohol-related difficulties.

MATERIALS
Product Number
Brand
Product Description
PHR1070
Supelco
Dehydrated Alcohol, Pharmaceutical Secondary Standard; Certified Reference Material
E-036
Supelco
Ethanol-400 (10 ampules/kit), 400 mg/dL in H2O, ampule of 10 × 1.2 mL, certified reference material, Cerilliant®
E-053
Supelco
Ethanol-500, 500 mg/dL in H2O, ampule of 10 × 1.2 mL, certified reference material, Cerilliant®
E-056
Supelco
Ethanol-20 (10 ampules/kit), 20 mg/dL in H2O, ampule of 10 × 1.2 mL, certified reference material, Cerilliant®
E-035
Supelco
Ethanol-25, 25 mg/dL in H2O, ampule of 10 × 1.2 mL, certified reference material, Cerilliant®
E-034
Supelco
Ethanol Calibration Kit, ampule of 10 × 1.2 mL, certified reference material, Cerilliant®
187380
Sigma-Aldrich
Ethyl alcohol, denatured, denatured, reagent grade
E-041
Supelco
Ethanol-150, 150 mg/dL in H2O, ampule of 10 × 1.2 mL, certified reference material, Cerilliant®
E-040
Supelco
Ethanol-10, 10 mg/dL in H2O, pack of 10 × 1.2 mL ampules, certified reference material, Cerilliant®
E-045
Supelco
Ethanol-40, 40 mg/dL in H2O, ampule of 10 × 1.2 mL, certified reference material, Cerilliant®
459844
Sigma-Aldrich
Ethyl alcohol, Pure, 200 proof, ACS reagent, ≥99.5%
32221
Sigma-Aldrich
Ethanol, puriss. p.a., absolute, ≥99.8% (GC)
E7023
Sigma-Aldrich
Ethyl alcohol, Pure 200 proof, Molecular Biology
E-029
Supelco
Ethanol-50, 50 mg/dL in H2O, ampule of 10 × 1.2 mL, certified reference material, Cerilliant®
E-033
Supelco
Ethanol-300, 300 mg/dL in H2O, ampule of 10 × 1.2 mL, certified reference material, Cerilliant®
E-030
Supelco
Ethanol-80, 80 mg/dL in H2O, ampule of 10 × 1.2 mL, certified reference material, Cerilliant®
E-031
Supelco
Ethanol-100 (10 ampules/kit), 100 mg/dL in H2O, ampule of 10 × 1.2 mL, certified reference material, Cerilliant®
E-032
Supelco
Ethanol-200 (10 ampules/kit), 200 mg/dL in H2O, ampule of 10 × 1.2 mL, certified reference material, Cerilliant®