Phenylpropanolamine 50mg / Chlorphenamine 4mg modified-release capsules

Introduction: Chlorpheniramine maleate (CPM) is a first-generation H1-antihistamine widely used for allergic conditions, yet its pharmacokinetic (PK) and bioavailability profiles across species remain poorly characterized. Understanding interspecies variability is critical for translational applications and the development of novel formulations. This review aims to summarize and critically evaluate the pharmacokinetics, bioavailability, species-specific behavior, mechanistic insights, and formulation-dependent variability of CPM, with emphasis on intranasal and buccal administration routes and their translational potential. Methods: We conducted a scoping review in accordance with PRISMA-ScR 2018 Guidelines on studies assessing CPM pharmacokinetics in hu-mans and animal models. The identification phases consisted of keyword terms mesh in PubMed: Search 1: Chlorpheniramine Bioavailability (n = 38), Search 2: Chlorpheniramine Bioequivalency (n = 14), and Search 3: Intranasal Chlorpheniramine (n = 54). Repeated or irrelevant studies were excluded, with a total of 22 studies analyzed, from which 13 are included in the final report. Results: CPM exhibits moderate oral bioavailability (25%-50%) and extensive tissue distribution, with a long elimination half-life (∼20 h). Intranasal and buccal routes demonstrate faster absorption and partial hepatic bypass. Bioequivalence studies reveal significant formulation-dependent variability, influenced by excipient design, release profiles, and stereochemistry. Conclusion: CPM remains a pharmacologically valuable molecule with underexplored delivery routes and applications. Standardization of formulations, population-specific pharmacokinetics, and further trials are warranted to unlock the full therapeutic potential of this approach beyond classical allergy treatment.

Abstract licence: CC BY

Purpose: To determine the effect of combining oseltamivir, artificial cow-bezoar, chlorphenamine maleate, and interferon inhalation on immune function and serum amyloid A (SAA) levels in children with influenza.
 Methods: A total of 114 children with influenza treated at the Second Affiliated Hospital of Hainan Medical University, Hainan Province, China from December 2019 to December 2022 were randomly divided into two groups, viz, study group (n = 57) and control group (n = 57). Control group received oseltamivir sodium chloride infusion, artificial cow-bezoar, and chlorphenamine maleate granules. Study group was treated with interferon alpha-1b in addition to control group treatment. Their clinical symptoms, duration of symptoms, immune function, SAA and C-reactive protein (CRP) levels were determined before and after treatment. Adverse reactions were also recorded.
 Results: Study group had a significantly shorter duration of fever, cough, sore throat, and nasal congestion after 5 days of treatment than control group (p < 0.05). The study group also showed higher CD3+ and CD8+ levels and lower CD4+ and CD4+/CD8+ levels than control group after treatment. However, both groups showed lower levels of SAA, CRP, and SAA/CRP after treatment than before treatment (p < 0.05). Furthermore, the levels of SAA, CRP, and SAA/CRP were lower in study group than in control group after treatment (p < 0.05). The incidence of adverse reactions in the study group after treatment was significantly lower than in the control group (p < 0.05).
 Conclusion: Quadruple therapy using oseltamivir, artificial cow-bezoar, chlorphenamine maleate, and interferon inhalation significantly shortens symptoms, boost immunity, lower SAA levels, and reduce side effects in children with influenza.

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A HPLC method has been described for simultaneous determination of Paracetamol, Phenylpropanolamine hydrochloride and Cetirizine hydrochloride in formulation. This method is based on HPLC separation of the three drugs on the Thermo Hypersil Gold C18 column (250 mm × 4.6 mm, 5.0µ), with isocratic conditions and mobile phase containing methanol: 0.01M disodium hydrogen phosphate dihydrate buffer [pH 7, adjusted with Ortho Phosphoric Acid (OPA)] (60: 40) at a flow rate of 1 ml/min, using UV detection at 217 nm. This method has been applied to formulation without any interference of excipients of formulation. The linear regression analysis data for the calibration plots showed a good linear relationship over the concentration range of 0.4-1.4µg/ml for Paracetamol, 7-12µg/ml for Phenylpropanolamine hydrochloride and 5-10µg/ml for Cetirizine hydrochloride respectively. The mean values of the correlation coefficient, slope and intercept were 0.9993, 51489 and 5844.4 for Paracetamol, 0.9991, 23235 and 70540 for Phenylpropanolamine hydrochloride and 0.9990, 40416 and 93404 for Cetirizine hydrochloride respectively. The method was validated as per the ICH guidelines. The limit of detection (LOD) and limit of quantitation (LOQ) was 0.2μg/ml and 0.4μg/ml for Paracetamol, 5μg/ml and 7μg/ml for Phenylpropanolamine hydrochloride and 4µg/ml and 5µg/ml for Cetirizine hydrochloride, respectively. Statistical analysis showed that the method is repeatable and selective for the estimation of Paracetamol, Phenylpropanolamine hydrochloride and Cetirizine hydrochloride.

Abstract licence: CC BY