Informatics Publishing Limited

R. Narayana Charyulu ¹, D. S. Sandeep ¹, Abhishiktha Alva ¹, Divya Rao ¹, Prashant Nayak ¹, Jobin Jose ¹, K. C. Bahrath Raj ²

Affiliations
1 Department of Pharmaceutics, NGSM Institute of Pharmaceutical Sciences, Nitte University, Paneer, Deralakatte, Mangalore, Karnataka, IN
2 Department of Pharmacology, NGSM Institute of Pharmaceutical Sciences, Nitte University, Paneer, Deralakatte, Mangalore, Karnataka, IN

Abstract

Fungal infections affecting nails are commonly seen around the world. The effectiveness of topical therapies is limited by minimal drug permeability through the nail plate. Nail permeability is however quite low and limits topical therapy to early/mild disease states such as onychomycosis (fungal infections of the nail). The current research aims at ungual drug delivery system as an effective treatment in nail infections. The formulations of nail lacquer were made with Amorolfine as antifungal agent using different concentration of polymer Eudragit RL 100 (ERL 100). Among 6 formulations, formulation F5 and F6 showed very good physical characteristics like viscosity, water resistance, stability, drying time, smoothness as compared to other formulations. The zone of inhibition of antifungal activity showed desired results (F5 and F6).

Keywords

Nail Lacquer, Polymer, Ungual Drug Delivary, Viscosity.

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Jobin Jose ¹, P. B. Ashwini ¹, Prashant Nayak ¹, R. Narayana Charyulu ¹

Affiliations
1 Department of Pharmaceutics, N.G.S.M. Institute of Pharmaceutical Sciences, NITTE Deemed to be University, Paneer, Deralakatte, Mangalore – 575018, IN

Abstract

Various dosage forms have been introduced in the recent days in the field of pharmaceutical technology. Transdermal patch is a technique from which a new drug delivery system that is oral dispersible film was developed. Oral dispersible films when they placed on mouth or oral cavity, they disintegrate or dissolve within a minute. Even though in a solid dosage form it doesn’t require chewing or drinking of water, which enhances the patient compliance. There are number of ingredients are used to formulate oral dispersible patches, like active pharmaceutical ingredients, polymers, flavouring agents, colouring agents etc, in which we can regard polymer as important ingredient which helps to form the film. Usually hydrophobic polymer are used for oral dissolving films which breaks down on the tongue or buccal cavity and then drug will go to systemic circulation. Fast disintegrating property, good mechanical property like mouth dissolving property of film can be achieved by water soluble polymer. Moreover in oral dispersible films, accurate and effective dosing can be accomplished in a safe manner.

Keywords

Oral Dispersible Films, Hydrophilic Polymers, Plasticizers, Solvent Casting.

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D. S. Sandeep ¹, K. M. Ashwin Raj ¹, V. Anoop Narayanan ¹, Akhilesh Dubey ¹, Jobin Jose ¹

Affiliations
1 Department of Pharmaceutical Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Paneer, Deralakatte, Mangaluru-575018, Karnataka, IN

Abstract

The drugs and medical devices for human use in Canada are regulated by Health Canada’s Therapeutic Products Directorate (TPD). Health Canada is responsible to implement the rules and regulations for the marketing of drugs. Health Canada’s process for approving new drugs is very slow and they give approval for drug products based on a complete review of safety and efficacy data. In Canada, around 70% of the new drugs were submitted over three months, and 40% more than one year, after their first submission. For drugs that were eventually approved to be marketed in Canada and in at least one of the other jurisdictions, the average delay from the first submission in either foreign jurisdiction to submission in Canada was 540 days. A drug approval process is completed by various applications submitted to the authority and the registration of drugs in Canada is really challenging. The purpose of this article is to provide information about the procedure from pre-submission to the marketing of a pharmaceutical drug for obtaining the drug approval in Canada.

Keywords

Health Canada, ANDS, CTA, HPFB, NDS.

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