Clindamycin Research Articles

Physico-Chemical Characterizations of Composited Calcium-Ortho-Phosphate Porous Particles and Their Controlled Release Behavior of Clindamycin Phosphate and Amikacin Sulfate

The porous particles prepared from composited calcium–ortho-phosphate (biphasic), Thai silk fibroin, gelatin, and alginate, with an organic to inorganic component ratio of 15.5:84.5, were tested for their abilities to control the release of the commercialized antibiotic solutions, clindamycin phosphate (CDP) and amikacin sulfate (AMK). The in vitro biodegradability tests complying to the ISO 10993-13:2010 standard showed that the particles degraded <20 wt% within 56 days. The drugs were loaded through a simple adsorption, with the maximum loading of injection-graded drug solution of 43.41 wt% for CDP, and 39.08 wt% for AMK. The release profiles from dissolution tests of the drug-loaded particles varied based on the adsorption methods used. The drug-loaded particles (without a drying step) released the drug immediately, while the drying process after the drug loading resulted in the sustained-release capability of the particles. The model-fitting of drug release profiles showed the release driven by diffusion with the first-ordered kinetic after the initial burst release. The released CDF and AMK from particles could sustain the inhibition of Gram-positive bacteria and Gram-negative bacteria, respectively, for at least 72 h. These results indicated the potential of these composited particles as controlled-release carriers for CDP and AMK.

Weighted-Incidence Syndromic Combination Antibiogram (WISCA) to Support Empirical Antibiotic Therapy Decisions in Infected Ischemic Leg Ulcers-A Feasibility Study.

Objective: Patients with peripheral artery occlusive disease (PAD) are at risk of developing foot ulcers, which can subsequently lead to foot infections and an increased risk of amputation. In cases of severe ischemic foot infections (IFIs), the empirical use of antibiotics can be limb-saving. However, there is currently no evidence-based guidance on the choice of empirical antibiotic therapy for IFI. Methods and Design: This retrospective single-center cohort study included 216 hospitalized patients with severe IFI undergoing endovascular revascularization. Weighted-Incidence Syndromic Combination Antibiograms (WISCAs) were calculated to guide empirical antibiotic choice. Results: The two most common causative pathogens for IFI were S. aureus and P. aeruginosa, with frequencies of 19.8% and 6.1%, respectively. The calculation of WISCAs revealed a low empirical coverage of amoxicillin (AMX) or clindamycin (CLN) with 21.6% and 27.7%, respectively. The empirical coverage of amoxicillin/clavulanic-acid (AMC), trimethoprim/sulfmethoxazole (SXT), and ciprofloxacin (CIP) was 50.6%, 53.1%, and 55.4%, respectively. Piperacillin/tazobactam (PT) exhibited the highest empirical coverage, with 82.5% as calculated by WISCAs. The calculated WISCAs did not significantly alter when stratified by the clinical characteristics of the patients. Conclusions: The empirical antibiotic coverage of CLN and AMX was low. SXT represents a promising empirical alternative in the case of IFI, irrespective of comorbidities and the WIfI score. WISCAs can assist in the decision-making process regarding empirical antibiotic therapy choices in cases of IFI.

Bioequivalence Analysis of Clindamycin Hydrochloride Capsules in Healthy Chinese Subjects Under Fasted and Fed Conditions.

Clindamycin is a lincosamide antibiotic for the treatment of staphylococcal, streptococcal, and anaerobic bacterial infections. We conducted a single-center, single-dose, 2-preparation, 2-period, 2-sequence, randomized, open-label, 2×2 crossover study to evaluate the pharmacokinetics (PKs) and safety of the test and reference clindamycin hydrochloride capsules in healthy Chinese subjects under both fasted and fed conditions. Forty-eight subjects were enrolled in the study totally, with 24 subjects in each group. All subjects were asked to take a test or reference preparation, under either fasted or fed condition, and their blood samples were collected and assayed by a validated high-performance liquid chromatography-tandem mass spectrometry method. PK parameters including maximum plasma concentration, area under the plasma concentration-time curve from time 0 to the last concentration, and area under the plasma concentration-time curve from time 0 to infinity were estimated with noncompartmental model and analyzed. Results showed that the PK profiles of the 2 preparations were consistent and met the bioequivalence criteria. Food was identified as a factor that had an impact on clindamycin absorption. The safety of clindamycin hydrochloride capsules was satisfactory. This study proved that the 2 clindamycin hydrochloride capsules were bioequivalent in healthy Chinese subjects under both fasted and fed conditions.

Exploring electrochemical mechanisms for clindamycin degradation targeted at the efficient treatment of contaminated water

Numerous studies reveal pollutants like clindamycin (CLD) in the environment, posing environmental and health risks. Conventional water treatment methods are ineffective at removing these contaminants, typically found in low concentrations. An innovative treatment approach is introduced through pre-concentration via adsorption, which is highly efficient, energy-saving, and reusable. The innovation uses solvents like methanol or ethanol to desorb pollutants, creating concentrated CLD solutions for more effective electrochemical degradation than conventional methods. Thus, this study explores, for the first time, the behavior of CLD electro-oxidation in different media—water, methanol, and ethanol—using a Dimensionally Stable Anode (DSA®-Cl₂). The study reveals distinct degradation mechanisms and offers new insights into solvent-assisted electrochemical treatments. After 30 min of electrolysis, all the current densities evaluated promoted significant degradation, ranging from 90 to 92%. The energy consumption was 2.9 Wh m⁻³ per percentage point at current densities of 2 and 3.5 mA cm⁻2. This demonstrates that using higher current densities over shorter electrolysis times is feasible, achieving removal rates of approximately 90%.The performance of chloride-based electrolytes was superior to that of sulfate-based electrolytes due to the ability of DSA®-Cl2 electrodes to generate reactive chlorine species more efficiently. A higher concentration of supporting electrolytes initially improved CLD removal, but no significant changes were observed after 1 h. Neutral pH conditions optimized CLD degradation, achieving up to 91% removal. Higher pollutant concentrations were associated with lower kinetic constants and decreased removal percentages. Methanol and ethanol enhanced removal rates to 98.3% and 92.3%, respectively, by generating oxidizing species such as methoxy, hydroxymethyl, and ethoxy radicals. The degradation by-products differed across the three media, with each solvent exhibiting distinct oxidation mechanisms. These findings highlight the potential of using methanol or ethanol as an electrolytic medium with efficiency comparable to water.

Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Male and Female Acne: Phase 3 Analysis.

Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel (CAB) is the only fixed-dose triple-combination treatment approved for acne. This post hoc analysis assessed the impact of sex on efficacy and safety/tolerability of CAB. In two multicenter, double-blind, phase 3 studies (NCT04214639 and NCT04214652), participants aged ≥9 years with moderate-to-severe acne were randomized (2:1) to 12 weeks of once-daily treatment with CAB or vehicle gel. Pooled data were analyzed by sex. Assessments included treatment success (≥2-grade reduction from baseline in Evaluator’s Global Severity Score and a score of 0 [clear] or 1 [almost clear]), inflammatory/noninflammatory lesion counts, Acne-Specific Quality of Life (Acne-QoL) questionnaire, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability. At week 12, treatment success rates were significantly greater with CAB versus vehicle irrespective of sex (females: 53.7% vs 23.0%; males: 43.1% vs 24.6%; P<0.05, both). CAB-treated female and male participants both experienced greater reductions from baseline versus vehicle in inflammatory (females: 77.7% vs 57.9%; males: 77.5% vs 57.1%; P<0.001, both) and noninflammatory lesions (females: 72.5% vs 45.6%; males: 72.3% vs 49.6%; P<0.001, both). Acne-QoL improvements from baseline to week 12 were significantly greater with CAB than vehicle. No significant differences in any efficacy measures between CAB-treated males and females were observed. Most TEAEs were of mild-to-moderate severity; no sex-based trends for safety/tolerability were observed. CAB demonstrated comparable efficacy, quality-of-life improvements, and safety in female and male participants with moderate-to-severe acne. As the first fixed-dose, triple-combination topical formulation, CAB represents an important new treatment for acne. J Drugs Dermatol. 2024;23(10):873-881. doi:10.36849/JDD.8484.

Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Participants With Moderate-to-Severe Acne: The Patient Journey.

Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose, triple-combination formulation approved for acne treatment. In 3 clinical studies of participants with moderate-to-severe acne, CAB demonstrated superior efficacy to vehicle and component dyads, with good safety and tolerability. Detailed efficacy/safety data from individual clinical study participants are presented. In two phase 3 (NCT04214652, NCT04214639) randomized, double-blind, 12-week studies, participants aged at least 9 years with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel. Descriptive data - including lesion count changes, treatment success (at least 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin), compliance, treatment-emergent adverse events (AEs), and cutaneous safety/tolerance assessments - were summarized from 6 CAB-treated cases. By week 12, all cases achieved >70% lesion reductions, 4/6 achieved treatment success, and 1/6 achieved a 2-grade reduction in severity. All cases were compliant with CAB treatment. No cases reported serious AEs. Transient increases occurred on cutaneous safety and tolerability assessments, with scores generally decreasing back to/below baseline levels by week 12. In two phase 3 clinical trials, fixed-dose, triple-combination CAB demonstrated good efficacy/safety. All 6 CAB-treated cases achieved substantial (>70%) lesion reductions, with 5/6 achieving treatment success or 2-grade reduction in severity by week 12. Transient cutaneous safety/tolerability severity increases generally resolved to baseline values by week 12. These clinical study cases reinforce the importance of patient education regarding adherence, expectations, and AEs. J Drugs Dermatol. 2024;23(11):1017-1024. doi:10.36849/JDD.8639.

Application Characteristics and Patient Preference of Triple-Combination vs Layered Topicals for Acne: Split-Face Study.

Although triple-combination therapies for acne are generally more efficacious than dual-combinations or topical monotherapy, this benefit may be offset by reduced adherence to a complicated treatment regimen. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB; Cabtreo®, Ortho Dermatologics) gel is the first triple-combination topical approved for the treatment of acne. By delivering multiple active ingredients as a fixed-dose combination, CAB gel may improve ease of use, which can benefit both treatment adherence and efficacy. The objective of this study was to compare the application characteristics of CAB gel with the layered application of its 3 individual active ingredients. In this split-face study, adults with acne-prone skin (N=25), self-applied CAB gel (0.3 cc) to 1 side of the face and layered benzoyl peroxide cream, adapalene gel, and clindamycin gel (0.1 cc each) on the opposite side. CAB and clindamycin gels were compounded with pyranine, which fluoresces under blue light. Photos taken under blue light were used to assess the uniformity of product application, and participants rated the evenness, speed, and ease of the 2 application regimens, as well as overall preference. Investigator-assessed evenness of application favored CAB gel over layered application in 100% of participants. All participants rated the application of CAB gel as more uniform, easier, and faster. Most (96%) preferred CAB gel for use at home. Fixed-dose CAB gel was applied more evenly than separate application of its 3 active ingredients. By addressing 3 of the main acne pathogenic pathways in a single, easy-to-apply formulation, CAB gel may improve the efficacy of and adherence to acne treatment. J Drugs Dermatol. 2024;23(10):857-861. doi:10.36849/JDD.8430.

Association of CovRS Two-Component Regulatory System with NADase Induction by Clindamycin Treatment in Streptococcus pyogenes.

Administration of high-dose clindamycin (CLI) and penicillin is recommended for the treatment of streptococcal toxic shock syndrome (STSS). However, CLI-resistant strains have been identified worldwide. In this study, some CLI-resistant strains demonstrated increased extracellular activity of the NAD-glycohydrolase (NADase) exotoxin following CLI treatment. These results support our previous conclusion that CLI-susceptible and CLI-resistant Streptococcus pyogenes strains exhibit CLI-dependent NADase induction. Furthermore, we investigated the mechanism of this phenomenon using 13 types of two-component sensor knockout strains derived from the CLI-susceptible strain 1529 that has a CLI-dependent NADase induction phenotype. Among the knockout strains, only 1529ΔcovS lost the phenotype. Additionally, 1529ΔspeB, 1529Δmga, and 1529Δrgg retained the CLI-dependent NADase induction phenotype. These findings indicate that CovS is related to this phenotype in a SpeB-independent manner.

Development and validation of High-Performance Thin Layer Chromatographic methods for simultaneous determination of antibacterial pharmaceutical formulations containing Clindamycin phosphate.

The main objective of this research is to establish and authenticate the High-Performance Thin-Layer Chromatographic techniques for the simultaneous assessment of Clindamycin phosphate in combination with Tretinoin (formulation-1) and Clindamycin phosphate with Adapalene (formulation-2), both of which are antimicrobial combinations. In the developed HPTLC methods, for combination-1, the optimized mobile phase was a mixture of n-Hexane: Ethyl acetate: ACN: Methanol (5:2:2:1 by volume) with observed Rf values of 0.413 and 0.787 for Clindamycin phosphate and Tretinoin, respectively. Similarly, for combination-2, the mobile phase comprised n-Hexane: Diethyl ether: Dichloromethane: Acetic acid (4:4:2:0.1 by volume) with recorded Rf values of 0.407 and 0.559 for Clindamycin phosphate and Adapalene, respectively. The developed methods are successfully validated as per the regulatory guidelines. This approach proves to be significantly time-saving and costeffective, rendering it suitable for routine analyses of the formulations containing selected antibacterial active pharmaceutical ingredients and commercial formulations.

A comparative evaluation of the antimicrobial efficacy of triple antibiotic paste, clindamycin, and linezolid as an intracanal medicament against Enterococcus faecalis: An in vitro study

ABSTRACT Aim: The aim of the present study was to evaluate and compare the antimicrobial efficacy of three medicaments, triple antibiotic paste (TAP), clindamycin (CLID), and linezolid (LZ) against Enterococcus faecalis, using spectrophotometry. Methods: Seventy-two single-rooted human premolars were collected and prepared using standard protocol and were decoronated to obtain standardized lengths. A pure culture of E. faecalis (ATCC 29212) was procured, grown on blood agar, obtained using a wired loop, and suspended in brain heart infusion (BHI) broth for 24 h. After contaminating the canals with E. faecalis, the prepared samples were divided into three groups, with 24 teeth each, based on the intracanal medicament used, Group A: TAP (ciplox×500 mg, metrogyl 400 mg, minoz 100 mg) + normal saline (NS), Group B: CLID (capsule clid 150) + NS, Group C: LZ (Lizoforce, dry syrup) + NS. The medicaments were syringed into the roots and which were then incubated. After 24 h, 12 samples per group were thoroughly rinsed for removal of intracanal medicaments (ICMs), and instrumented using #4 GG drill to obtain dentinal shavings, which were allowed to fall into sterile BHI broth. The turbidity of the broth was assessed and the optical density (OD) was recorded using spectrophotometer to estimate the concentration of E. faecalis after 1 day. After a period of 7 days, the remaining 12 samples per group underwent identical processing. Results: At the end of day 1, all three antibiotics presented comparable values of OD indicating comparable antimicrobial efficacy. Group-wise comparison revealed that TAP continued to be superior to the other two antibiotics even at the end of 7 days. However, the difference was significant only between TAP and LZ with no significant difference between TAP and CLID and between CLID and LZ. Conclusion: The present study concludes that the use of single-antibiotic CLID and LZ may serve as an effective alternative to the multidrug combination TAP, as an ICM.

Clindamycin phosphate-based deep eutectic solvent as a chiral selector for enantioseparation of amino alcohol drugs in nonaqueous capillary electrophoresis

Clindamycin phosphate (CP) exhibits good enantioselectivity for many basic drugs, but its separation effect for most amino alcohol drugs is not satisfactory. In this work, a deep eutectic solvent (DES) chiral selector based on CP was prepared for the first time and utilized as a single chiral selector in nonaqueous capillary electrophoresis (NACE) to separate twelve amino alcohol drugs. Compared with unmodified CP, the separations of model drugs in the DES chiral selector system were significantly improved. Most amino alcohol drugs could be completely separated, and the peak shapes were good. In addition, we used infrared spectroscopy and nuclear magnetic resonance method to study the specific separation mechanism and explored the reasons why DES chiral selector has better enantioselectivity. This work is the first to directly modify antibiotic chiral selector into DES, indicating a direction for us to develop novel chiral recognition materials.

Modified minimally invasive surgical technique with clindamycin-augmented or non-augmented platelet-rich fibrin in periodontal regeneration: A randomized clinical trial.

Injectable platelet-rich fibrin (I-PRF), a second-generation platelet concentrate, is widely used to enhance soft and hard tissue healing alone or in combination with biomaterials, relying on its harboring of various pivotal growth/differentiation factors. This randomized trial assessed the effect of clindamycin (CLN) augmented injectable platelet-rich fibrin (I-PRF) with modified minimally invasive surgical technique (M-MIST) versus I-PRF alone with M-MIST on the clinical and radiographic parameters in the management of periodontal intra-bony defects in patients with stage-III grade B periodontitis. This is a 9-month parallel-grouped, two arm, double-blinded, randomized controlled trial (RCT) that included 28 patients (n = 28) with stage-III grade B periodontitis, who were allocated randomly to test- (CLN/I-PRF + M-MIST, 50 μL of CLN per 1 mL of I-PRF; n = 14) or control-group (I-PRF + M-MIST; n = 14). Clinical attachment level (CAL; primary outcome), probing depth (PD), gingival margin level (GML), plaque index (PI), and gingival index (GI) were recorded at baseline, 3, 6, and 9 months, whereas radiographic parameters radiographic linear defect depth (RLDD), and radiographic defect area (RDA) were recorded at baseline, 6, and 9 months. The CLN release kinetics from the I-PRF were further characterized. Compared to baseline, both groups independently demonstrated significant improvements in CAL, PD, GML, GI, PI, RLDD and BDA at 3, 6 and 9 months (p < .05). A significant reduction in CAL measurements was noticeable in the CLN/I-PRF + M-MIST and I-PRF + M-MIST group independently over time (p < .05). CLN/I-PRF + M-MIST showed significantly lower CAL than PRF + M-MIST group at baseline, after three as well as 9 months (p < .05). Intergroup comparisons at 9 months demonstrated that CAL-gain was non-significant between groups (p > .05), GI significantly lower in CLN/I-PRF + M-MIST, whereas PD-reduction significantly higher I-PRF + M-MIST group (p < .05). CLN was steadily released for the I-PRF for up to 48 h, with a peak concentration at 24 h, which then gradually declined till the seventh day. I-PRF with M-MIST provided significant clinical and radiographic improvement up to 9 months postoperatively in stage-III grade B periodontitis. CLN, at the applied concentration and release duration, does not appear to further positively impact these observed I-PRF effects.

The Surfactant Properties of Clindamycin as a Useful Adjunct for Removing Ruptured Silicone Implants.

Silicone gel removal after breast implant rupture is a difficult task. Silicone is hydrophobic and thus cannot be irrigated effectively with saline. Attempts at mechanical removal with sponges are often partially successful. Incomplete removal results in persistent silicone contamination with possible local inflammation, infection, and silicone granulomata. In this partially quantitative investigation, we assess the de-adhesion ability of different clindamycin formulations against known surfactant controls when combined with silicone gel. To demonstrate surfactant properties in vitro, clindamycin phosphate, clindamycin hydrochloride, and a known surfactant, sodium dodecyl sulfate (SDS), were compared. An amount of 170 g of silicone gel placed in a dry glass container exhibited strong adherence to the container walls. In separate trials, clindamycin phosphate (300 mg in 100 mL), clindamycin HCl (300 mg in 100 mL), and SDS (1 g in 100 mL) solutions with normal saline were added to the silicone aggregate, and de-adhesion properties were compared. All solutions aided in the de-adhesion of the sticky silicone from glass substrate. The SDS had the strongest effect, followed by clindamycin phosphate and then clindamycin HCl. The observed interactions suggested that all of the solutions behaved as ionic surfactant coating the silicone with negative charges via adsorption. However, the phosphate anionic formulation was associated with a greater surfactant effect than HCl. Clindamycin acts as a surfactant to aid in the clinical removal of ruptured silicone gel. Clindamycin phosphate seems to have a stronger effect than clindamycin HCl, likely related to the negative charges on the phosphate groups.

52946 Efficacy and Safety of a Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Black Participants with Moderate-to-Severe Acne

52946 Efficacy and Safety of a Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Black Participants with Moderate-to-Severe Acne

52858 Efficacy of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne: Comparison of 4 Clinical Trials

52858 Efficacy of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne: Comparison of 4 Clinical Trials

Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne: Comparison of 4 Clinical Trials

Introduction: Combination therapies targeting multiple processes of acne pathogenesis are recommended for most acne patients. A three-pronged approach using an antibiotic, retinoid, and antibacterial may also increase treatment efficacy versus monotherapy or dual-combination products. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (BPO) polymeric mesh gel (CAB) is the first fixed-dose, triple-combination topical approved by the FDA for the treatment of acne. The objective of this analysis was to compare treatment success and effect size of once-daily CAB with its three constituent dyad gels, branded adapalene 0.3%/BPO 2.5% gel, and vehicle across four clinical studies. Methods: Two phase 2 (NCT03170388, NCT04892706) and two phase 3 (NCT04214652, NCT04214639) double-blind, randomized, 12-week studies enrolled participants with moderate-to-severe acne. In all studies, treatment success at week 12 (defined as a ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin) was a co-primary endpoint. Other co-primary endpoints (reduction from baseline in inflammatory and noninflammatory lesions) are not shown here. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were also assessed. A post hoc analysis of number needed to treat (NNT)—the number of patients who need to be treated with an intervention for one additional patient to achieve success versus vehicle—was performed to provide an additional measure of treatment effect and to indirectly compare data across studies. Results: Across studies, approximately half of CAB-treated participants achieved treatment success by week 12 (range: 49.6-52.5%) versus less than one-fourth with vehicle (range: 8.1%-24.9%; P&lt;0.01, all) and less than one-third with component dyads or branded adapalene 0.3%/BPO 2.5% (range: 27.8%-32.9%; P≤0.001, all). Treatment success rates were significantly greater for all active treatments versus vehicle (P&lt;0.01, all). NNT values for CAB (3-5) were lower (better) than for constituent dyads (5-6) or branded adapalene 0.3%/BPO 2.5% (7), further indicative of greater efficacy. TEAEs with CAB were mostly of mild-to-moderate severity. TEAE and discontinuation rates were similar or lower with CAB gel than with adapalene/BPO dyad gels. Mean cutaneous safety/tolerability scores with CAB gel were &lt;1 (mild) at all timepoints. Conclusions: CAB gel demonstrated significantly greater efficacy in the treatment of moderate-to-severe acne than dyad gels and branded adapalene 0.3%/BPO 2.5% gel, with approximately half of participants achieving clear/almost clear skin by 12 weeks with CAB. Due to acne pathogenesis, a triple-combination treatment may result in clinical success more often than two-ingredient combination products. Funding: Ortho Dermatologics.

Impact of Age on Efficacy and Safety of Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Participants with Moderate-to-Severe Acne

Introduction: Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the first fixed-dose, triple-combination formulation approved for the treatment of acne. In three clinical studies of participants with moderate-to-severe acne, CAB gel demonstrated superior efficacy to vehicle and component dyads, with good safety/tolerability. As acne pathogenesis and treatment outcomes can vary with age, this post hoc analysis was performed to evaluate the efficacy and safety of CAB in pediatric and adolescent participants (aged 9-24 years) versus adult participants (≥25 years). This age cutoff was chosen as acne in patients aged 18-24 years is more similar to adolescents than adults, and age 25 is often used to define “adult acne”. Methods: In a phase 2 (NCT03170388) and two phase 3 (NCT04214652, NCT04214639) studies, participants aged ≥9 years with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel. Endpoints included percentage of participants achieving treatment success (defined as ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin) and least-squares mean percent change from baseline in inflammatory/noninflammatory lesion counts at week 12. Treatment-emergent adverse events (TEAEs) were also assessed. Pooled data across all three studies were analyzed for participants aged 9-24 years (CAB: n=297; vehicle: n=218) or ≥25 years (n=91; n=51). Results: At week 12, approximately half of CAB-treated participants in both age groups achieved treatment success (9-24 years: 50.6%; ≥25: 49.0%) versus less than one-fourth with vehicle (15.7% and 20.6%; P&lt;0.01, both). Treatment with CAB resulted in &gt;70% reductions from baseline in inflammatory and noninflammatory lesions in both age groups, versus 45%-62% with vehicle (P≤0.001, all). There were no significant differences between CAB-treated participants in the two age groups across any of these efficacy endpoints (P=0.68-0.97). Most TEAEs with CAB were of mild-moderate severity, with no age-related trends in safety/tolerability. Conclusions: Fixed-dose, triple-combination CAB gel was efficacious and well tolerated in participants with moderate-to-severe acne, regardless of age. Approximately half of pediatric/adolescent and adult participants achieved clear/almost clear skin with CAB, and lesion count reductions of &gt;70% were observed. Funding: Ortho Dermatologics

New insight into the mitigation strategy of microbiologically influenced corrosion caused by anaerobic microbial consortium based on resource conversion of obsolete antibiotics

In this work, the diversity of microbial consortium coming from a shale gas well was initially analyzed by 16 S full length sequencing, and the primary bacteria are Arciella (53.37 %), Shewanella (43.61%), and Desulfovibrio (1.95 %). These bacteria can produce large amounts of H2S using sulfate as electron acceptor. Subsequently, microbiologically influenced corrosion (MIC) behavior and MIC inhibition mechanism of norfloxacin and clindamycin hydrochloride are studied. The bacteria in anaerobic microbial consortium (AMC) significantly accelerate steel corrosion, but norfloxacin and clindamycin hydrochloride both can effectively inhibit MIC at a low concentration (40 mg/L) with inhibition efficiencies of 85.2 % and 82.7 %, respectively.

EE404 A Cost-Effectiveness Analysis of a Triple-Agent Topical Fixed-Dose Combination of 1.2% Clindamycin Phosphate, 0.15% Adapalene, and 3.1% Benzoyl Peroxide Gel for the Treatment of Moderate-to-Severe Acne Vulgaris in the United States

EE404 A Cost-Effectiveness Analysis of a Triple-Agent Topical Fixed-Dose Combination of 1.2% Clindamycin Phosphate, 0.15% Adapalene, and 3.1% Benzoyl Peroxide Gel for the Treatment of Moderate-to-Severe Acne Vulgaris in the United States

Chromatographic and Spectrophotometric Determination of Clindamycin in Pharmaceutical Products

Accurate, precise, and reliable chromatographic and spectrophotometric methods were developed for determining clindamycin (CLD) in pharmaceutical formulations. The spectrophotometric method was adopted for flow injection analysis (FIA). The method is based on the online oxidation of CLD and measuring the absorbance of the resulting product using a flow cell at 605 nm. Experimental conditions, including FIA variables and reaction conditions, were optimized. The chromatographic separation was achieved using a C8 column and an isocratic mobile phase. The composition of the mobile phase selected for the analysis consists of a mixture of phosphate buffer (50%), MeOH (35%), and ACN (15%), adjusted to a pH of 3.47 by phosphoric acid. The eluent was monitored with a UV detector at 205 nm. The linearity range was 10–200 and 50–800 µg/mL for the FIA and HPLC, respectively. The applicability of the FIA and HPLC methods was validated by analyzing CLD in synthetic and commercial pharmaceutical products. No significant interferences were observed from the common excipients usually used in commercial formulations.