Delving into the Latest Updates on Cefprozil with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Brisoral, Cefprozil (USP), Cefprozil anhydrous

+ [15]

Target

PBPs

Mechanism

PBPs inhibitors(Bacterial penicillin-binding protein inhibitors), Cell wall inhibitors

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Respiratory Tract InfectionsBacterial Infections

Inactive Indication

Gram-Negative Bacterial InfectionsGram-Positive Bacterial InfectionsLower Respiratory Tract Infections

Originator Organization

Corden Pharma Latina SpA

Active Organization

Sino-American Shanghai Squibb Pharmaceuticals Ltd.

Inactive Organization

Corden Pharma Latina SpA

Drug Highest PhaseApproved

First Approval Date

US (23 Dec 1991),

Gram-Negative Bacterial InfectionsGram-Positive Bacterial Infections

Regulation-

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Structure

Molecular FormulaC18H21N3O6S

InChIKeyALYUMNAHLSSTOU-PFBPGKLMSA-N

CAS Registry121123-17-9

Cefprozil Tablets provided by Wenling Innovation Biotechnology Co., Ltd. were used as the test preparation. According to the relevant provisions of the bioequivalence test, the absorption rate and degree of the two preparations in healthy humans were compared with those of Cefprozil Tablets (reference preparation) produced by Lupin Limited to investigate the bioequivalence of the two preparations in humans.

Start Date29 Jun 2023

Sponsor / Collaborator

Wenling City Innovation Biotechnology Co., Ltd.

CTR20231452 / CompletedNot Applicable

头孢丙烯片在健康受试者中单中心、随机、开放、两制剂、单次给药、两周期、双交叉空腹/餐后生物等效性试验

[Translation] A single-center, randomized, open-label, two-dose, single-dose, two-period, double-crossover fasting/fed bioequivalence study of cefprozil tablets in healthy subjects

主要目的：以药代动力学参数作为主要终点评价指标，分别比较在空腹/餐后状态下口服受试制剂头孢丙烯片（生产厂家：悦康药业集团股份有限公司）与参比制剂头孢丙烯片（生产厂家：Lupin Limited）后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。次要目的：观察受试制剂头孢丙烯片和参比制剂头孢丙烯片在健康受试者中的安全性。

[Translation]

Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation indicators, the pharmacokinetic behavior of the test preparation Cefprozil Tablets (manufacturer: Yuekang Pharmaceutical Group Co., Ltd.) and the reference preparation Cefprozil Tablets (manufacturer: Lupin Limited) in healthy subjects after oral administration in the fasting/postprandial state was compared to evaluate the bioequivalence of the two preparations. Secondary purpose: Observe the safety of the test preparation Cefprozil Tablets and the reference preparation Cefprozil Tablets in healthy subjects.

Start Date16 Jun 2023

Sponsor / Collaborator

Yuekang Pharmaceutical Group Co., Ltd.

CTR20230982 / CompletedNot Applicable

广东恒健制药有限公司生产的头孢丙烯片（按 C18H19N3O5S 计，250mg）与Lupin LTD持证的头孢丙烯片（按C18H19N3O5S 计，250mg）在健康受试者中的单次给药、随机、开放、两周期、双交叉、空腹及餐后状态下的生物等效性研究

[Translation] A single-dose, randomized, open-label, two-period, double-crossover bioequivalence study of cefprozil tablets (250 mg, calculated as C18H19N3O5S) produced by Guangdong Hengjian Pharmaceutical Co., Ltd. and cefprozil tablets (250 mg, calculated as C18H19N3O5S) certified by Lupin LTD in healthy subjects under fasting and fed conditions

主要研究目的：以 Lupin LTD 持证的头孢丙烯片（按 C18H19N3O5S 计，250mg）为参比制剂，以广东恒健制药有限公司生产的头孢丙烯片（按C18H19N3O5S计，250mg）为受试制剂，通过单中心、随机、开放、单次给药、两周期、双交叉临床研究来评价两种制剂在空腹及餐后状态下的人体生物等效性。次要研究目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

The main purpose of the study is to use Lupin LTD's licensed cefprozil tablets (calculated as C18H19N3O5S, 250mg) as the reference preparation and Guangdong Hengjian Pharmaceutical Co., Ltd.'s cefprozil tablets (calculated as C18H19N3O5S, 250mg) as the test preparation, and to evaluate the bioequivalence of the two preparations in the fasting and fed state through a single-center, randomized, open, single-dose, two-period, double-crossover clinical study. Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date22 Apr 2023

Sponsor / Collaborator

Jiangmen Hengjian Pharmaceutical Co. Ltd.

100 Clinical Results associated with Cefprozil

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100 Translational Medicine associated with Cefprozil

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100 Patents (Medical) associated with Cefprozil

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330

Literatures (Medical) associated with Cefprozil

01 Feb 2024·Therapeutic delivery

Aquasomes nanoformulation for controlled release of drug and improved effectiveness against bacterial infections

Article

Author: Shanmugam, Bhuvaneshwari ; Srinivasan, Umashankar Marakanam

Aim: The study aimed to develop and evaluate an aquasome drug-delivery system for controlled drug delivery of cefprozil monohydrate. Materials & methods: Aquasomes were prepared by the spinal method with a calcium phosphate core, sugar-coated using cellobiose and drug-loaded by adsorption. The formulations were characterized for size, morphology and drug release. An antibacterial study was conducted for Gram-positive and -negative bacteria. Results: It showed particle size of 2791.9 nm, zeta potential of -0.3 mV with good stability, and 99.08% of drug loading and drug release were controlled and prolonged, achieving 56% within 8 h and possessing potential for 100% release beyond 12 h. Conclusion: An aquasome drug-delivery system was developed for novel controlled drug delivery for pharmaceutical antibiotic therapeutics.

01 Jan 2024·The journal of allergy and clinical immunology. In practice

Assessing Pediatric Cephalosporin Allergic Reactions Through Direct Graded Oral Challenges

Article

Author: Kim, Vy ; Gabrielli, Sofianne ; McCusker, Christine ; O'Keefe, Andrew ; Ben-Shoshan, Moshe ; Atkinson, Adelle ; Abrams, Elissa M ; Sillcox, Carly ; Eiwegger, Thomas ; Copaescu, Ana-Maria

BACKGROUND:

Cephalosporins, β-lactam antibiotics, commonly cause allergic reactions.

OBJECTIVE:

To assess the clinical characteristics and management of pediatric patients with suspected cephalosporin allergy using direct graded oral challenges (GOCs).

METHODS:

Children referred for suspected cephalosporin allergy at 4 Canadian clinics were recruited over 10 years. Data on demographics, clinical reaction characteristics, and management were collected through a questionnaire. Patients underwent a direct GOC (initially 10% of the treatment dose, then 90% after 20 min), and reactions were monitored 1 week postchallenge. Families were contacted annually for up to 5 years to detect subsequent antibiotic reactions. Logistic regression analysis identified factors associated with positive GOC reactions.

RESULTS:

Among the 136 patients reporting cephalosporin allergy, 75 (55.1%) were males with a median age of 3.9 years (interquartile range 2.3-8.7). Cefprozil represented the most common cephalosporin linked to the index reaction (67.6% of cases). Of the 136 direct GOCs, 5.1% had an immediate and 4.4% a nonimmediate reaction, respectively. Positive GOCs conducted in children with a history of skin-limited nonsevere rashes were classified as mild, benign skin rashes. Positive GOCs were more likely in children with food allergies (adjusted odds ratio 1.14; 95% confidence interval [95% CI] 1.00-1.29).

CONCLUSIONS:

Direct GOCs are safe and effective for diagnosing pediatric cases that report nonvesicular skin-limited symptoms while being treated with cephalosporins.

01 Dec 2023·Clinical pharmacology in drug development

Pharmacokinetic and Bioequivalence Evaluation of Two Cefprozil Dispersible Tablets in Healthy Chinese Volunteers

Article

Author: Su, Jianfen ; Muhetaer, Halimulati ; Liang, Zhimin ; Zhang, Canhua ; Huang, Chen ; Tang, Yukuan ; Xu, Lang ; Fu, Xihua

Abstract:

This study aimed to assess the bioequivalence of 2 cefprozil dispersible tablet formulations (250 mg) in healthy Chinese volunteers under fasting and fed conditions and to determine the pharmacokinetics of cefprozil. A randomized, single‐dose, open‐label, 2‐formulation, 2‐period study was conducted. The elimination period for this study was 7 days. Forty‐eight healthy volunteers received 250‐mg cefprozil dispersible tablets in each study period under both test and reference conditions. The test and the reference cefprozil were bioequivalent in healthy Chinese volunteers, and there was no significant food effect in individuals receiving either formulation. No serious adverse event was recorded, and no volunteers withdrew from the study.

100 Deals associated with Cefprozil

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External Link

KEGG	Wiki	ATC	Drug Bank
D00261	Cefprozil	J01DC10	DB01150

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Respiratory Tract Infections	FR	-	02 Nov 1997
Bacterial Infections	CH	-	28 Dec 1996
Gram-Negative Bacterial Infections	US	Corden Pharma Latina SpA	23 Dec 1991
Gram-Positive Bacterial Infections	US	Corden Pharma Latina SpA	23 Dec 1991

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Lower Respiratory Tract Infections	Phase 1	CN	-	08 Oct 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04414254 (Pubmed \| Adv Ther)	Phase 1	-	60	Cefprozil for Suspension	ragoaarbvj(dhaklfphgi) = jddtsnhnxd ncnwbqgzut (pqkwsjmjmp ) View more	-	01 Feb 2021
				Granule Formulation	ragoaarbvj(dhaklfphgi) = ksgwmkpiii ncnwbqgzut (pqkwsjmjmp ) View more
NCT00840866 (CTgov)	Phase 1	-	39	Cefprozil (Cefprozil (Test))	cavdtprrug(faykdfoelg) = jmedowqqhf helubcheur (ewvxbrqzvn, hzvaxaeppb - lzpagsfvqz) View more	-	21 Jul 2009
				Cefzil (Cefzil® (Reference))	cavdtprrug(faykdfoelg) = dfsplozkgl helubcheur (ewvxbrqzvn, brsoqgxswl - txzydftcwt) View more
NCT00835354 (CTgov)	Phase 1	-	26	Cefprozil (Cefprozil (Test))	ojjolsmbgc(mzufkfpllj) = jppzmxkcri vgdjdmpmaz (klhwgikanm, zdyhffwkrc - ehciznrdip) View more	-	21 Jul 2009
				Cefzil (Cefzil® (Reference))	ojjolsmbgc(mzufkfpllj) = xxbywdytwq vgdjdmpmaz (klhwgikanm, wdyuqynibs - zzjtakqgfb) View more
NCT00840281 (CTgov)	Phase 1	-	38	Cefprozil (Cefprozil (Test))	mxqwqpqvlo(wlmkpfuzeh) = tqyuyqtoze lghqxqrsdb (pdcorohncw, byzhgabdgh - xytvvtmfbs) View more	-	21 Jul 2009
				Cefzil (Cefzil® (Reference))	mxqwqpqvlo(wlmkpfuzeh) = wxcqtkrnlo lghqxqrsdb (pdcorohncw, delrartlyo - kykafhctda) View more
NCT00835614 (CTgov)	Phase 1	-	26	Cefprozil (Cefprozil (Test))	jqekvaihjd(cyegertewo) = fwapcfypis vehvjepqsk (rrqmbbdlsk, cgtpceanyz - neduqyfpum) View more	-	21 Jul 2009
				Cefzil (Cefzil® (Reference))	jqekvaihjd(cyegertewo) = zfzyrrvkri vehvjepqsk (rrqmbbdlsk, mbbsujqhig - gbchkksavh) View more