SM Journal of Pharmacology and Therapeutics

Archive Articles

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A Botanical Nano Ozonated Composition with Maximum Bioavailability for Hemorrhoids

The present patent-pending invention relates to a topical pharmaceutical nano composition (with maximum bioavailability) for hemorrhoids was developed.

Random clinical study on 100 volunteers showed very fast and effective relief of hemorrhoids on all patients of both sexes. For severe bleeding cases it was observed hemorrhoids disappeared in less than one week. Observed results showed excellent results for all ages with no adverse or side effects.

Awad Mansour¹* and Ammar Mansour²


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Preclinical Characterization of CTL-1, A Biosimilar Anti-EGFR Monoclonal Antibody for Cetuximab

The monoclonal antibody (mAb) market has helped millions of patients across the globe in treating serious and chronic diseases. The expiry of patents for the first generation of approved therapeutic mAbs has led to the development and authorization of biosimilar alternatives for which the market is of great interest due to the demand of affordable treatments. Here we report the preclinical development of a biosimilar mAb to cetuximab (Erbitux®) referred to as CTL-1. Analyses of the physicochemical properties and biological activities of both CTL 1 and cetuximab were performed to allow for comparisons of the primary structure, glycoform heterogeneity, in vitro anti-tumor activity, and in vivo pharmacokinetics, tissue distribution, and efficacy of the two antibodies. Our results confirm that CTL-1 has the same amino acid sequence and a similar glycosylation profile as the cetuximab reference. In vitro bioassays indicate that CTL-1 and cetuximab achieve comparable dose-dependent inhibition of EGFR+ tumor cell proliferation, and maintain similar abilities to induce Antibody-Dependent Cell Mediated Cytotoxicity (ADCC). Preclinical studies in mice confirm that the proposed biosimilar to cetuximab is comparable with regard to its pharmacokinetic and tissue distribution properties as well as its ability to reduce tumor growth in vivo. Based on these comprehensive similarity studies, CTL-1 was confirmed to be highly similar to the reference mAb cetuximab and is suggested as a viable biosimilar alternative to this important therapeutic mAb.

Peisheng Hu¹#, Ryan Graff²#, Long Zheng¹, Leslie A Khawli¹* and Alan L Epstein¹*


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Fabrication of Topical Piroxicam Emulgel: In Vitro and Ex Vivo Assessments

Emulgel (Emulsion in gel) have emerged as one of the most interesting topical drug delivery system as it has dual release control system i.e. emulsion and gel. Also the stability of emulsion is increased when it is incorporated in gel. Piroxicam is an orally or topically active NSAID. The objective of this work was to develop an emulgel for control delivery for Piroxicam. In present work we prepare emulsion and then incorporated in gel base. An attempt has been made to make use of three different gelling agents, which will release the drug effectively on the surface when it is applied topically. Twelve semisolid formulations belongs to HPMC, Poloxamer 407 and Carbopol 934 (0.5%w/w) were prepared and evaluated for various physicochemical parameters like physical appearance, pH, extrudability, drug content uniformity, spreadability and viscosity. In vitro drug release rate was determined through diffusion method using pre-hydrated cellophane membrane. Ex vivo studies were performed through rat skin by using Franz diffusion cell. The results of studies revealed that the optimized emulgel indicated 1-35 µm globule size. The pH were found is in the range of 6.7 (F11) to 7.4 (F2). The optimized formulation F2 showed good spreadability as well as maximum drug content. The optimized emulgel showed 75.6% release in 8 hours. The optimized emulgel showed drug permeation through rat skin up to 36.5%. Hence it can be concluded that emulsion based system is more effective and safe system for sustain delivery of NSAID(s).

Manasa Boda¹, Sundeep Chaurasia² and Prasad Vure²*