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CE

cefaclor (Raniclor / Raniclor)

✓ Approved

Ranbaxy Laboratories Limited · Small Molecule · Small Molecule

What is cefaclor?

cefaclor is a small molecule developed by Ranbaxy Laboratories Limited. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesRaniclor, Raniclor
CompanyRanbaxy Laboratories Limited
Drug ClassSmall Molecule
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Ranbaxy Laboratories Limited

Therapeutic Indications

cefaclor is developed for 6 unique indications across 3 therapeutic areas.

Therapeutic AreaConditionPhase
Infections and infestationsLower respiratory tract infection✓ Approved
Infections and infestationsOtitis media✓ Approved
Infections and infestationsTonsillitis✓ Approved
Infections and infestationsUrinary tract infection✓ Approved
Respiratory, thoracic and mediastinal disordersTonsillar inflammation✓ Approved

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Related Research Articles

PubMedEuropean journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology2026-08-07

Comparison of oral third- versus first-/ second-generation cephalosporins for acute uncomplicated cystitis: a nationwide retrospective cohort study.

Taniguchi Jumpei J, Aso Shotaro S, Yasunaga Hideo H

Oral cephalosporins are frequently prescribed for uncomplicated cystitis. Although cephalexin and cefaclor (first- and second-generation oral cephalosporins) exhibit favorable pharmacokinetic properties, third-generation agents demonstrate lower and more variable bioavailability, potentially resulting in reduced clinical effectiveness. This study compared oral third-generation cephalosporins with cephalexin and cefaclor in treating uncomplicated cystitis. We conducted a retrospective cohort study using a nationwide claims database in Japan (2006-2022). We included adult women aged ≥ 18 years who newly received oral third-generation (cefdinir, cefpodoxime proxetil, cefditoren pivoxil, or cefcapene pivoxil) or first-/second-generation cephalosporins (cephalexin or cefaclor) for acute uncomplicated cystitis, with a prescription duration of 5-7 days. The primary outcome was a composite of pyelonephritis diagnosis or additional antibiotic use within 7 days. Secondary outcomes included the individual primary outcome components, all-cause hospitalization, and adverse events. We conducted propensity-score overlap weighting to adjust for possible confounders and stratified analyses by age (< 50 or ≥ 50 years). Among 40,003 eligible patients, 90.7% received third-generation cephalosporins. The proportion of the primary outcome was significantly higher in the third-generation group than in the first-/second-generation group (8.4% vs. 6.5%; risk difference, 1.9%; 95% confidence interval, 1.0%-2.7%). Among the secondary outcomes, additional antibiotic treatment was more frequent in the third-generation group, whereas the proportions of pyelonephritis diagnosis and other outcomes were similar between the groups. Subgroup analyses showed consistent results across age strata. Oral third-generation cephalosporins may be associated with more frequent additional antibiotic treatment compared with cephalexin or cefaclor in the management of uncomplicated cystitis.

PMID 42565893
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PubMedInternational journal of biological macromolecules2026-08-07

Crosslinked gelatin pastilles prepared via maillard reaction as oral dosage form of ionic liquid pharmaceuticals.

Ng Liu Han LH, Chew Li Ying LY, Yeo Ying Tong YT, Teo Eng Hui EH et al.

Ionic liquid pharmaceuticals (ILP) represent a new class of pharmaceuticals that can circumvent the issues of low aqueous solubility and polymorphism prevalent in pharmaceutical crystals. Due to their highly viscous and hygroscopic nature, ILPs must be formulated into solid dosage forms to ensure their shelf-life stability and dosing accuracy. Gelatin is widely used as carrier matrix for ILPs owed to its high compatibility with various ILPs. Gelatin-based dosage forms, however, exhibit poor storage stability, thereby necessitating reinforcement of the gelatin matrix. The present work investigated the feasibility of employing Maillard reaction (MR)-mediated crosslinking of gelatin with sugars to enhance the storage stability of chewable ILP-loaded gelatin pastilles, while simultaneously conferring taste-masking properties to them. Ionic-liquid pair of poorly-soluble drug ibuprofen (IBU) and 1-butyl-3-methylimidazolium (BMIM) was used as the model ILP. The effects of the degree of gelatin crosslinking, which was modulated by stevia: glucose ratio, on the quality attributes (e.g., dosage uniformity, IBU-BMIM release) and storage stability of the pastilles were evaluated. The results showed MR-mediated crosslinking preserved the liquid-like form of IBU-BMIM in the pastilles, without adverse effect on IBU-BMIM content (≈30 wt%) and its entrapment efficiency (>95 wt%). The pastilles prepared at stevia: glucose = 75:25 (w/w) exhibited 80 wt% IBU-BMIM release after 120 min (intact dosage), high dosage uniformity, and comparable texture/taste profiles as commercial chewable drug tablets. Importantly, the pastilles exhibited good stability after one-month accelerated storage (40°C and 75% relative humidity), as reflected by minimal changes in their quality attributes and high microbiological safety.

PMID 42551677
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PubMedApplied biosafety : journal of the American Biological Safety Association2026-08-07

Repurposing Success: Real-World Validation of a Novel Cephalosporin Decontamination Protocol Using Chlorine Dioxide and Disc Diffusion Testing.

Tancock-Jones Rhys R, Kyriakidis Sofianos S, Cole Brett B, Martens Jeremy J

Beta-lactam manufacturing facilities face strict regulatory challenges to repurposing for non-beta-lactam production due to the high risk of cross contamination. This study introduces a novel decontamination protocol for cephalosporin facilities, combining chlorine dioxide (ClO2) treatment with disc diffusion testing to verify the complete degradation and inactivation of beta-lactam residues in a real-world setting. Antimicrobial susceptibility discs (ASDs) contaminated with cephalosporins (Cefalexin, Cefaclor, Cefixime, Cefuroxime) were exposed to both aqueous (400 ppm for 24 h) and gaseous ClO2 (5 mg/L for >5 h) in separate cycles, achieving a minimum cumulative exposure of 9600 ppm-hours in both. Post-treatment, replicates (4 = aqueous cycle, 5 = gaseous cycle) of each cephalosporin were analyzed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) and microbial challenge testing to assess degradation and biological inactivation, respectively. For all, LC-MS/MS confirmed cephalosporin degradation below the reporting limit (<0.02 μg/disc), while microbial challenge testing demonstrated no significant biological activity with <1 mm bacterial inhibition. Microbial challenge and LC-MS/MS results showed significant agreement (Cohen's κ = 1.00) in both aqueous and gaseous ClO2 cycles. Gaseous ClO2 application at 9600 ppm-hours was applied to a 450 m2 cephalosporin facility. Analysis confirmed that cephalosporin residues were degraded to levels below the acceptable limits (<1 μg/disc) with microbial challenge testing supporting the success of the cycle, with no significant biological activity remaining in the discs placed throughout the facility. This study presents the first successful protocol for cephalosporin facility decontamination using gaseous ClO2 in a real-world setting.

PMID 42564646
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PubMedFarmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria2026-08-06

Determinants of adherence to calcium/vitamin D supplements in a cross-sectional study.

Gómez-Costas Daniel D, de Lorenzo-Pinto Ana A, Iznaola-Muñoz Covadonga C, Carrillo-Burdallo Anaís A et al.

Adherence to combined calcium and vitamin D supplements is often suboptimal, yet the independent role of formulation attributes (pharmaceutical form, organoleptic profile, acceptability) remains understudied. The aim was to estimate Calcium/Vitamin D adherence in real-world practice and to identify associated factors, with particular emphasis on formulation characteristics and patient-perceived acceptability. Population-based analytical cross-sectional study (STROBE guidelines). Random telephone interviews were conducted with 360 participants from a tertiary hospital catchment area in Madrid, with active prescriptions for over 6 months, complementing the data with electronic dispensing records. Global adherence was defined as the simultaneous fulfillment of: self-reported adherence >90%, a Morisky-Green result compatible with adherence, and ≥90% of expected dispensations in the previous 6 months. Formulations were classified a priori into five organoleptic groups based on their sweetener and flavor profile. Acceptability was assessed using 1-5 Likert scales for taste, texture, and overall rating. Univariate and multivariable logistic regression were used to identify factors associated with adherence. Twenty-two different formulations were identified. Global adherence was 34.7% (95% CI: 30.0-39.8). Agreement between measures was moderate (κ = 0.38-0.60). Self-reporting (70.8%) significantly overestimated adherence compared to dispensing records (40.3%). Chewable tablets showed higher adherence than orodispersible and effervescent forms. In the multivariable model, adherence was independently associated with female sex (aOR 2.69; 95% CI: 1.59-4.59), polypharmacy (>10 drugs) (aOR 2.32; 95% CI: 1.32-4.07), polyol-based organoleptic group (aOR 2.43; 95% CI: 1.26-4.77) and overall rating of 5/5 (aOR 6.17; 95% CI: 3.16-12.50). Adverse reactions (reported by 15.3% of participants) reduced the probability of adherence (aOR 0.24; 95% CI: 0.08-0.58). Forgetfulness was the main reason for non-adherence (63.8%), followed by organoleptic problems and intolerance. The model showed good discrimination (Area under the curve 0.83). Strict adherence to calcium/vitamin D is low, and self-reporting substantially overestimates actual compliance. Beyond classical patient-level factors, formulation tolerability and acceptability emerge as independent, potentially modifiable determinants of adherence. A simple screening strategy based on patient overall rating, adverse reactions and formulation organoleptic profile could guide early, pragmatic interventions such as adherence support and timely formulation switching.

PMID 42557115
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PubMedDaru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences2026-07-30

Three-dimensional printing as a transformative platform for patient-centric pediatric drug delivery: technologies, formulation strategies and clinical translation.

Phadte Padmadip P, Jeedigunta Mythili Krishna MK, Rao Gopalkrishna G, Chellampillai Bothiraja B

Pediatric patients require age-appropriate dosage forms because developmental differences in physiology, pharmacokinetics and swallowing ability can significantly affect therapeutic outcomes. Conventional dosage forms are often unsuitable for children and practices such as tablet splitting, crushing or extemporaneous preparation may lead to dose inaccuracy, altered stability, poor palatability and reduced adherence. These limitations highlight the need for innovative formulation strategies that provide precise dosing while improving acceptability and therapeutic effectiveness. In this context, three-dimensional (3D) printing has emerged as a promising platform for personalized pediatric drug delivery. This review critically examines recent advances in 3D printing technologies for pediatric drug delivery and provides a formulation-focused and translational perspective by integrating pediatric therapeutic needs with technology selection, polymer considerations and dosage form design flexibility. A comprehensive literature review was conducted to evaluate recent developments in pediatric pharmaceutical applications of 3D printing. Major technologies including fused deposition modeling, semi-solid extrusion, binder jet printing and inkjet printing were assessed with respect to formulation design, polymer selection, drug-polymer compatibility and pediatric suitability. Particular emphasis was placed on taste-masking approaches, personalized dosing capability and dosage adaptability for different pediatric age groups. Three-dimensional printing enables fabrication of diverse pediatric-friendly dosage forms including chewable gummies, mini-tablets, orodispersible films and confectionery-like formulations. Published studies demonstrated improved dose precision, effective taste masking, customizable drug release profiles and enhanced patient acceptability. Regulatory approval of Spritam further supports the clinical feasibility of this technology. However, challenges remain regarding printer calibration, reproducibility, limited pharmaceutical-grade printable materials, long-term stability and regulatory harmonization. Three-dimensional printing represents an important advancement in patient-centric pediatric pharmacotherapy by enabling precise control over dose, geometry, release kinetics and sensory attributes. This review highlights its practical potential and translational readiness for pediatric healthcare.

PMID 42530696
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PubMedParasites & vectors2026-07-28

Efficacy of a single oral administration of a formulation of fluralaner, moxidectin and pyrantel (BRAVECTO® TriUNO) in dogs for the treatment and prevention of angiostrongylosis.

Rohdich Nadja N, Chiummo Rafael R, Zschiesche Eva E, Raulf Marie-Kristin MK et al.

Four studies investigated the efficacy of fluralaner/moxidectin/pyrantel chewable tablets (Bravecto® TriUNO) in preventing and treating canine angiostrongylosis; one study also included a formulation of fluralaner/milbemycin oxime. Studies included eight or 10 dogs/group. In Studies 1 and 2 (prevention), dogs inoculated with third-stage larvae of Angiostrongylus vasorum on day - 31 or - 28 were randomized to groups by sex and body weight; in Studies 3 and 4 (treatment) by faecal first-stage larvae counts at approximately 8 weeks post-inoculation (PI). All studies included an untreated control group (CG). Study 1 included three groups treated with formulations of moxidectin/fluralaner/pyrantel; minimum moxidectin doses 0.0125, 0.025 or 0.055 mg/kg. The formulation with moxidectin at 0.025 mg/kg, 99.0% effective in preventing establishment of infection, was adopted as the investigational veterinary product (IVP) for the following studies. Study 2 included a group treated with either the IVP or a combination of fluralaner (10 mg/kg) with milbemycin oxime (0.75 mg/kg) (IVP-2). In all studies, the IVP was administered once on day 0; in Study 2, IVP-2 was administered on days 0, 31, 62 and 93. In Study 1, efficacy was determined by reductions in geometric mean necropsy worm counts approximately 33 days post-treatment versus mean CG counts, in the other studies by reductions in mean faecal L1 counts. Study 2 assessed pulmonary changes via thoracic computed tomography. Respiratory signs and serological antibody responses were monitored. In Study 1, all moxidectin doses exceeded 90% efficacy. In Study 2, IVP efficacy (one treatment) at 62 days was 100.0%; IVP-2 (four treatments) efficacy was 99.8% at 124 days. Respiratory signs were absent or lower in IVP-treated than CG dogs. In Studies 3 and 4, IVP efficacy was 100% by 3 and 4 weeks post-treatment, respectively. In all studies, lungworm count reductions in the IVP groups were statistically significant (P < 0.0001) versus the CG. Serology confirmed A. vasorum infections in all control and IVP-2-treated dogs, and absence of infections in IVP-treated dogs. Treatments were well tolerated. A single treatment with Bravecto TriUNO is highly effective in preventing angiostrongylosis and eliminating established A. vasorum infections. Infection-related lung pathology was reduced in treated dogs.

PMID 42509566
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