[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

摘要

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.

材料

产品编号

品牌

产品描述

E7023

Sigma-Aldrich

乙醇，Pure 200纯度, Molecular Biology

459844

Sigma-Aldrich

纯乙醇, 200 proof, ACS reagent, ≥99.5%

459828

Sigma-Aldrich

纯乙醇, 200 proof

493546

Sigma-Aldrich

纯乙醇, 200 proof, meets USP testing specifications

459836

Sigma-Aldrich

纯乙醇, 200 proof, anhydrous, ≥99.5%

E7148

Sigma-Aldrich

乙醇，Pure 190纯度, for molecular biology

493511

Sigma-Aldrich

纯乙醇, 190 proof, ACS spectrophotometric grade, 95.0%

51976

Sigma-Aldrich

酒精, BioUltra, Molecular Biology, ≥99.8%, (absolute alcohol, without additive, A15 o¹)

270741

Sigma-Aldrich

酒精试剂, suitable for HPLC, denatured

362808

Sigma-Aldrich

酒精试剂, reagent grade

PHR1070

Supelco

无水乙醇, Pharmaceutical Secondary Standard; Certified Reference Material

493538

Sigma-Aldrich

纯乙醇, 190 proof, meets USP testing specifications

187380

Sigma-Aldrich

乙醇，变性, reagent grade, denatured

02857

Sigma-Aldrich

酒精, purum, fine spirit, denaturated with 4.8% methanol, F25 METHYL¹, ~96% (based on denaturant-free substance)

02483

Supelco

酒精, standard for GC

E-029

Supelco

乙醇-50标准液 CRM, 50 mg/dL in H₂O, ampule of 10 × 1.2 mL, certified reference material, Cerilliant^®

E-033

Supelco

乙醇-300标准液 CRM, 300 mg/dL in H₂O, ampule of 10 × 1.2 mL, certified reference material, Cerilliant^®

277649

Sigma-Aldrich

酒精试剂, anhydrous, ≤0.003% water

E-040

Supelco

乙醇-10标准液 CRM, 10 mg/dL in H₂O, pack of 10 × 1.2 mL ampules, certified reference material, Cerilliant^®

E-030

Supelco

乙醇-80 标准液 CRM, 80 mg/dL in H₂O, ampule of 10 × 1.2 mL, certified reference material, Cerilliant^®

E-031

Supelco

乙醇-100（10支/盒)标准液 CRM, 100 mg/dL in H₂O, ampule of 10 × 1.2 mL, certified reference material, Cerilliant^®

32221

Sigma-Aldrich

酒精, puriss. p.a., absolute, ≥99.8% (GC)

676829

Sigma-Aldrich

酒精试剂, anhydrous, ≤0.005% water

48075

Supelco

Ethanol 溶液, certified reference material, 2000 μg/mL in methanol

29221

Sigma-Aldrich

酒精, tested according to Ph. Eur.

E-053

Supelco

乙醇-500标准液 CRM, 500 mg/dL in H₂O, ampule of 10 × 1.2 mL, certified reference material, Cerilliant^®

E2385

Supelco

10% (v/v) 乙醇标准品, 10 % (v/v) in H₂O, analytical standard

E-041

Supelco

乙醇-150, 150 mg/dL in H₂O, ampule of 10 × 1.2 mL, certified reference material, Cerilliant^®

E-032

Supelco

乙醇-200 (10支/盒)标准液 CRM, 200 mg/dL in H₂O, ampule of 10 × 1.2 mL, certified reference material, Cerilliant^®

E-036

Supelco

乙醇-400（10支/盒)标准液 CRM, 400 mg/dL in H₂O, ampule of 10 × 1.2 mL, certified reference material, Cerilliant^®