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Jose, Jobin
- Formulation and Evaluation Ungual Drug Delivery System of Antifungal Agent for Nail Disorders
Abstract Views :156 |
PDF Views:1
Authors
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
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
Source
Research Journal of Pharmacy and Technology, Vol 10, No 3 (2017), Pagination: 869-872Abstract
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.- Oral Dispersible Films, Novel Technology for the Delivery of Drugs
Abstract Views :184 |
PDF Views:0
Authors
Affiliations
1 Department of Pharmaceutics, N.G.S.M. Institute of Pharmaceutical Sciences, NITTE Deemed to be University, Paneer, Deralakatte, Mangalore – 575018, IN
1 Department of Pharmaceutics, N.G.S.M. Institute of Pharmaceutical Sciences, NITTE Deemed to be University, Paneer, Deralakatte, Mangalore – 575018, IN
Source
Research Journal of Pharmacy and Technology, Vol 12, No 1 (2019), Pagination: 425-428Abstract
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.References
- Irfan M, Khan A. orally disintegrating film: A modern Expansion in drug delivery system. 2016; 24(5):537-546.
- Scarpa M, Stegemann S, Hsiao WK. Orodispersilble films: Towards drugs delivery in special population. International Jornal of Pharmaceutics. 2017;523(1):327-335.
- Chandra A, Pathak K, Sharma V. Fast dissolving oral films:An innovative drug delivery system and dosage form. International Journal of chemistry and technological research. 2010;2(1):576-583.
- Vijendar C, Sudheer Kumar D, Krishnaveni J. Formulation and evaluation of fast dissolving oral films of diazepam. Journal of pharmacovigilance. 2016;4(3):2329-6887.
- Hoffmann M E, Beitenbach A, Breitkreutz J. Advances in orodispersable films for drug delivery. Expert opinion in drug deliv. 2011;8(3):299-316
- Jose J, Netto G. Role of solid lipid nanoparticles as photoprotective agents in cosmetics. journal Cosmetic Dermatology. 2018; 00:1–7. https://doi.org/10.1111/jocd.12504.
- Bhyan B, Jangra S, Kaur M, Singh H. Orally fast dissolving films: Innovations in formulation and technology. International Journal of Pharmaceutical science review and research. 2011;9(2): 50-57.
- Mashru RC, Sutariya VB, Sankalia MG, Parikh PP. Development and evaluation of fast-dissolving film of salbutamol sulphate. Drug Dev Ind Pharm. 2005;35:25–34
- Joshua JM, Hari R, Jyothish KF et al. Fast dissoliving oral thin films an effective dosage form for quick release. International Journal of Pharmaceutical Sciences Review and Research. 2016;38(1):282-289
- Pathare YS, Hastak VS, Bajaj AN. Polymers used for fast disintegrating oral films. International Journal of pharmaceutics science and research. 2013;21(1):169-178.
- Raghuraman S, Velrajan G, Ravi R, Jeyabalan B, Benito Johnson D, Sankar V. Design and evaluation of propranolol hydrochloride buccal films. Indian Journal of Pharmaceutical Sciences. 2002;64:32–6.
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- Sharma D, Kauri D, Varma S et al. Fast dissolving oral films technology:a recent trend for an innovative oral drug delivery system. International Journal of Drug Delivery. 2015;7(2):60-75.
- Mashru RC, Sutariya VB, Sankalia MG, Parikh PP. Development and evaluation of fast dissolving film of salbutamol sulphate. Drug Develoment and Industrial Pharmacy. 2005;31:25–34.
- Jose J, Charyulu RN. Prolonged drug delivery system of an antifungal drug by association with polyamidoamine dendrimers. International Journal of Pharmaceutical Investigation.2016; 6(2):123–127.
- Deepthi S, Jose, J. Novel hydrogel-based ocular drug delivery system for the treatment of conjunctivitis. International Ophthalmology. 2018; https://doi.org/10.1007/s10792-018-0955-6.
- Ali MS, Vijendar C, Kumar SD, Krishnaveni J. Formulation and evaluation of fast dissolving oral films of diazepam. Journal of pharmacovigilance. 2016;4:210.
- Regulatory Approval Process for Drugs in Canada-A Challenging Task
Abstract Views :379 |
PDF Views:0
Authors
Affiliations
1 Department of Pharmaceutical Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Paneer, Deralakatte, Mangaluru-575018, Karnataka, IN
1 Department of Pharmaceutical Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Paneer, Deralakatte, Mangaluru-575018, Karnataka, IN
Source
Research Journal of Pharmacy and Technology, Vol 12, No 7 (2019), Pagination: 3206-3210Abstract
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.References
- Ali Shajarizadeh MA, Aiden Hollis. Delays in the submission of new drugs in Canada. CMAJ. 187(1), Jan 2015:47-51.
- Canada H, Products H, Branch F, Products Directorate T. mands_gespd-eng.pdf.[cited 2018 May 02]. Available from: https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhpmps/alt_formats/pdf/prodpharma/applic-demande/guide-ld/mgmt-gest/mands_gespd-eng.pdf.
- Distribution and marketing of drugs in Canada: Overview. [cited 26 April 2018]. Available from:https://content.next.westlaw.com/Document/Iffa811f25ac111e598dc8b09b4f043e0/View/FullText.html?contextData=(sc.Default) & transition Type=Default & first Page = true & bhcp=1
- DSM Sinochem Pharmaceuticals. Drug products. [cited 27 April 2018]. Available from: http://www.dsm-sinochem.com/About-Us/Our-global-network/Drug-Products.
- Government of Canada HC. Description: Appendix 6c: Abbreviated New Drug Submission (ANDS) or Supplement to an Abbreviated New Drug Submission (SANDS). [cited 2018 May 01]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/compli-conform/noccg_accd-longdesc3-eng.php
- How drugs are reviewed in Canada. [cited 27 April 2018]. Available from:https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fact-sheets/drugs-reviewed-canada.html.
- Lexchin J. Health Canada’s use of its priority review process for new drugs: A cohort study. BMJ Open 2015;5: e006816. doi:10.1136/bmjopen-2014- 006816. Available from: http://dx.doi.org/10.1136/
- Mulaje SS. Procedure for drug approval in different countries: A Review. J Drug Deliv Ther. 3(2); 2013:1–21.
- Preeti MS et.al. New drug approval procedure in different countries: A Review. Int J Chem Tech Res. 10(12), 2017:1-21.
- Regulating Pharmaceutical Drugs- Health Canada. [cited 2018 April 27]. Available from: http://www.oagbvg.gc.ca/internet/English/parl_oag_201111_04_e_35936.html.
- Richard YC, Goodwin SH. An overview of Canadian and U.S. Approaches to drug regulation and responses to post market adverse drug reactions. J Diabetes Sci Technol. 7(2); 2013: 313-320.
- Shakeel SM et.al. Comparison of regulatory requirements for generic drugs dossier submission in United states and Canada. Int J Pharm Sci and Health care. 6(6); 2016: 1-19.