[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of clindamycin palmitate hydrochloride granules in Chinese healthy volunteers after meal administration

按有关生物等效性试验的规定，选择Pharmacia and Upjohn Co为持证商的盐酸克林霉素棕榈酸酯颗粒（商品名：Cleocin Pediatric®，规格：按克林霉素（C18H33ClN2O5S）计75mg/5ml）为参比制剂，对海南海神同洲制药有限公司生产的受试制剂盐酸克林霉素棕榈酸酯颗粒（规格：5ml:75mg（按C18H33ClN2O5S计））进行餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在餐后给药条件下的生物等效性。

[Translation]

In accordance with the relevant provisions of bioequivalence tests, clindamycin palmitate hydrochloride granules (trade name: Cleocin Pediatric®, specification: 75 mg/5 ml calculated as clindamycin (C18H33ClN2O5S)) produced by Pharmacia and Upjohn Co was selected as the reference preparation, and a human bioequivalence study of postprandial administration was conducted on the test preparation clindamycin palmitate hydrochloride granules (specification: 5 ml: 75 mg (calculated as C18H33ClN2O5S)) produced by Hainan Haishen Tongzhou Pharmaceutical Co., Ltd. was conducted to compare whether the absorption rate and degree of the drug in the test preparation were within an acceptable range with those of the reference preparation, and to evaluate the bioequivalence of the two preparations under postprandial administration conditions.

Start Date03 Nov 2023

Sponsor / Collaborator

Hainan Haishen Tongzhou Pharmaceutical Co Ltd.

CTR20223173 / CompletedNot Applicable

盐酸克林霉素棕榈酸酯颗粒在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

按有关生物等效性试验的规定，选择Pharmacia and Upjohn Co为持证商的盐酸克林霉素棕榈酸酯颗粒（商品名：Cleocin Pediatric®，规格：按克林霉素（C18H33ClN2O5S）计75mg/5ml）为参比制剂，对海南海神同洲制药有限公司生产的受试制剂盐酸克林霉素棕榈酸酯颗粒（规格： 75mg/5ml（按C18H33ClN2O5S计））进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹和餐后给药条件下的生物等效性。

[Translation]

In accordance with the relevant provisions of bioequivalence tests, clindamycin palmitate hydrochloride granules (trade name: Cleocin Pediatric®, specification: 75 mg/5 ml calculated as clindamycin (C18H33ClN2O5S)) produced by Pharmacia and Upjohn Co was selected as the reference preparation, and the test preparation clindamycin palmitate hydrochloride granules (specification: 75 mg/5 ml (calculated as C18H33ClN2O5S)) produced by Hainan Haishen Tongzhou Pharmaceutical Co., Ltd. was subjected to a human bioequivalence study on fasting and fed administration. The differences in the absorption rate and extent of the drug in the test preparation and the reference preparation were compared to see whether they were within an acceptable range, and the bioequivalence of the two preparations under fasting and fed administration conditions was evaluated.

Start Date17 Mar 2023

Sponsor / Collaborator

Hainan Haishen Tongzhou Pharmaceutical Co Ltd.

CTR20213347 / CompletedNot Applicable

盐酸克林霉素棕榈酸酯颗粒在健康受试者中空腹/餐后单次口服给药、随机、开放、两序列、两周期、交叉生物等效性试验

[Translation] A randomized, open-label, two-sequence, two-period, crossover bioequivalence study of clindamycin palmitate hydrochloride granules in healthy volunteers after single oral administration on an empty stomach or after a meal

通过空腹/餐后试验研究，考察中国健康受试者在空腹/餐后条件下单剂量口服北大医药股份有限公司生产的盐酸克林霉素棕榈酸酯颗粒（规格：75mg（按克林霉素计））与持证商Pharmacia and Upjohn Co的盐酸克林霉素棕榈酸酯颗粒（规格：75mg/5mL）后的体内药代动力学特征，评价两制剂的生物等效性。

[Translation]

The fasting/postprandial test study was conducted to investigate the in vivo pharmacokinetic characteristics of clindamycin palmitate granules (specification: 75 mg (calculated as clindamycin)) produced by Peking University Pharmaceutical Co., Ltd. and clindamycin palmitate granules (specification: 75 mg/5 mL) produced by the licensed supplier Pharmacia and Upjohn Co. in healthy Chinese subjects after a single oral dose under fasting/postprandial conditions, and to evaluate the bioequivalence of the two preparations.

Start Date05 Jan 2022

Sponsor / Collaborator

PKU HealthCare Corp., Ltd.

100 Clinical Results associated with Clindamycin Palmitate Hydrochloride

100 Translational Medicine associated with Clindamycin Palmitate Hydrochloride

100 Patents (Medical) associated with Clindamycin Palmitate Hydrochloride

Literatures (Medical) associated with Clindamycin Palmitate Hydrochloride

01 Aug 2020·AAPS PharmSciTechQ3 · MEDICINE

Formulation Optimization of Selective Laser Sintering 3D-Printed Tablets of Clindamycin Palmitate Hydrochloride by Response Surface Methodology

Q3 · MEDICINE

Article

Author: Barakh Ali, Sogra F ; Kuttolamadom, Mathew A ; Mohamed, Eman M ; Rahman, Ziyaur ; Dharani, Sathish ; Ozkan, Tanil ; Khan, Mansoor A

The aims of the current study were to develop and evaluate clindamycin palmitate hydrochloride (CPH) 3D-printed tablets (printlets) manufactured by selective laser sintering (SLS). Optimization of the formulation was performed by studying the effect of formulation and process factors on critical quality attributes of the printlets. The independent factors studied were laser scanning speed, microcrystalline cellulose (MCC), and lactose monohydrate (LMH) concentration. The responses measured were printlets weight, hardness, disintegration time (DT), and dissolution in 30 min. The printlets were characterized for content uniformity, chemical interactions, crystallinity, drug distribution, morphology, and porosity. The laser scanning speed showed statistically significant effects on all the studied dependent responses (p < 0.05). MCC showed statistically significant effects on hardness, DT, and dissolution (p < 0.05), while LMH showed statistically significant effect on hardness and dissolution (p < 0.05). The model was validated by an independent formulation, and empirical values were in close agreement with model-predicted values. X-ray powder diffraction and differential scanning calorimetry data suggested a decrease in crystallinity of the LMH in the printlets. X-ray micro-CT scanning showed porous microstructure of the printlets with a porosity 24.4% and 31.1% for the printlets printed at 200 and 300 mm/s laser speed, respectively. In summary, the SLS method provides an opportunity to fabricate customized dosage forms as per patients' need.

01 Dec 2014·BMC Pharmacology and ToxicologyQ4 · MEDICINE

An outpatient antibacterial stewardship intervention during the journey to JCI accreditation

Q4 · MEDICINE

ArticleOA

Author: Ping Song ; Quan Zhou ; Wei Li

BACKGROUNDAntibacterial overuse, misuse and resistance have become a major global threat. The Joint Commission International (JCI) accreditation standards include quality improvement and patient safety, which is exemplified by antimicrobial stewardship. There are currently few reports on interventions to improve the quality of outpatient antibacterial prescribing.METHODSA before-after intervention study, aiming at antibacterial use in outpatients, was performed in a university-affiliated hospital with 2.8 million outpatient visits annually during the journey to JCI accreditation (March of 2012 - March of 2013). Comprehensive intervention measures included formulary adjustment, classification management, motivational, information technological, educational and organizational measures. A defined daily dose (DDD) methodology was applied. Pharmacoeconomic data and drug-related problems (DRPs) were statistically compared between the two phases.RESULTSThe variety of antibacterials available in outpatient pharmacy decreased from 38 to 16. The proportion of antibacterial prescriptions significantly decreased (12.7% versus 9.9%, P < 0.01). The proportion of prescriptions containing the restricted antibacterials was 30.4% in the second phase, significantly lower than the value of 44.7% in the first phase (P < 0.01). The overall proportion of oral versus all antibacterial prescriptions increased (94.0% to 100%, P < 0.01) when measured as defined daily doses. Statistically significant increases in relative percentage of DDDs of oral antibacterials (i.e., DDDs of individual oral antibacterial divided by the sum of DDDs of all antibacterials) were observed with moxifloxacin, levofloxacin, cefuroxime axetil, ornidazole, clindamycin palmitate, cefaclor, amoxicillin and clarithromycin. Occurrence rate of DRPs decreased from 13.6% to 4.0% (P < 0.01), with a larger decrease seen in surgical clinics (surgical: 19.5% versus 5.6%; internal medicine: 8.4% versus 2.8%, P < 0.01). The total expenditure on antibacterials for outpatients decreased by 34.7% and the intervention program saved about 6 million Chinese Yuan Renminbi (CNY) annually.CONCLUSIONThe one-year intervention program on outpatient antibacterial use during the journey to JCI accreditation reduced the expenditure on antibacterials, improved the appropriateness of antibacterial prescriptions. Quality improvements need integrated multifaceted intervention measures and long-term adherence to the antibiotic stewardship. Approach of i.v. to oral antibacterial switch, classification management, and motivational measures may play the most efficient role in changing antibacterial prescription practices.

01 Dec 2008·Journal of Pharmaceutical and Biomedical AnalysisQ3 · MEDICINE

Identification, isolation and characterization of impurities of clindamycin palmitate hydrochloride

Q3 · MEDICINE

Article

Author: Ch. Bharathi ; V. Bhargavi ; A. Naidu ; V.K. Handa ; Ramesh Dandala ; M. Saravana Kumar ; Joseph Sunder Raj ; P. Jayaram

Clindamycin palmitate hydrochloride is a water soluble hydrochloride salt of the ester of clindamycin and palmitic acid. It is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin. Total 12 impurities at levels ranging from 0.05% to 0.5% were detected by isocratic reverse-phase high performance liquid chromatography (HPLC) using RI detector. The molecular weights of impurities were determined by LC-MS analysis. Two impurities were starting materials and the remaining impurities were isolated from crude samples/enriched mother liquors using reverse-phase preparative HPLC. Based on the spectral data the structures of these impurities were characterized as, clindamycin palmitate sulphoxides alpha-/beta-isomers (impurity I); clindamycin laurate (impurity II); lincomycin palmitate (impurity III); clindamycin myristate (impurity IV); epiclindamycin palmitate (impurity V); clindamycin palmitate 3-isomer (impurity VI); clindamycin pentadecanoate (impurity VII); clindamycin B-palmitate (impurity VIII); clindamycin heptadecanoate (impurity IX) and clindamycin stearate (impurity X). Structural elucidation of all impurities by spectral data ((1)H NMR, (13)C NMR, MS and IR) and formation of these impurities have been discussed in detail.

100 Deals associated with Clindamycin Palmitate Hydrochloride

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Indication	Country/Location	Organization	Date
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