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Tamil Selvan, A.
- Study on Role of Postmarketing Surveillance in New Drug Development
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Authors
Affiliations
1 Department of Pharmacology, Teegala Ram Reddy College of Pharmacy, Saroor Nagar, Meerpet, Hyderabad – 97, IN
2 Department of Management Studies Thiyagaraja College of Arts and Science, Madurai, IN
3 Periyar College of Pharmaceutical Sciences, Tiruchirappalli-21, IN
1 Department of Pharmacology, Teegala Ram Reddy College of Pharmacy, Saroor Nagar, Meerpet, Hyderabad – 97, IN
2 Department of Management Studies Thiyagaraja College of Arts and Science, Madurai, IN
3 Periyar College of Pharmaceutical Sciences, Tiruchirappalli-21, IN
Source
Asian Journal of Management, Vol 4, No 1 (2013), Pagination: 12-15Abstract
Post marketing surveillance aims to monitor and evaluate both the beneficial and adverse effects of drugs after approval for general use. The Health Council in the Netherlands has defined post marketing surveillance (PMS) as 'The systematic surveillance and scientific study of all intended and unintended effects of medicines on human health, after their release for marketing'. Spontaneous reports should be supplemented by analytical studies, monitoring of cohorts of users of new drugs, using record-linkage to track their subsequent outcomes and to interpret the results of such analyses in the context of variability of drug exposure. Furthermore, the introduction of drugs with a new pharmacological profile especially requires post marketing surveillance of adverse events, as illustrated by the case of ibopamine. Programs for collecting and reporting safety information on drugs such as adverse drug reactions include an adverse drug reaction reporting system undertaken by pharmaceutical companies, the drug safety information reporting system undertaken by medical personnel, and the WHO International Drug Monitoring Program whereby drug safety information is exchanged among various countries. The present work has been designed to create awareness and knowledge about the post-marketing surveillance research and its emerging role in the new drug development.Keywords
Post Marketing Surveillance, Pharmaceutical, Drug Monitoring
References
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- Strom BE (ed). Pharmacoepidemiology. Chichester: John Wiley & Sons, third edition, 2000.
- Friedman MA, Woodcock J, Lumpkin MM, Shuren JE, Hass AE, Thompson LJ. The safety of newly approved medicines: do recent market removals mean there is a problem? JAMA 1999; 281:1728-34.
- Meyboom RHB, Egberts ACG, Gribnau FWJ Hekster YA. Pharmacovigilance in perspective. Drug Saf 1999; 21:429-47.
- Temple R. Meta-analysis and epidemiologic studies in drug development and postmarketing surveillance. JAMA 1999; 281:841-4.
- Bemt MLA van den, Egberts TCG, de Jong-van den Berg LTW, Brouwers JRBJ. Drug related problems in hospitalised patiensts. Drug Safe 2000; 22:321-33.
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- Waller PC, Wood SM, Breckenridge AM, Rawlins MD. Why the Safety Assessment of Marketed Medicines (SAMM) guidelines are needed. Br J Clin Pharmacol 1994; 38:93.
- Leufkens HG, Urquhart J. Variability in patterns of drug usage. J Pharm Pharmacol 1994; 46 Suppl 1:433-37.
- Purgative Activity of Caesalpinia pulcherrima (L) Sw Leaves Extracts
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Authors
Affiliations
1 Department of Pharmacology, Teegala Ram Reddy College of Pharmacy, Saroor Nagar, Meerpet, Hyderabad-97, IN
1 Department of Pharmacology, Teegala Ram Reddy College of Pharmacy, Saroor Nagar, Meerpet, Hyderabad-97, IN
Source
Research Journal of Pharmacology and Pharmacodynamics, Vol 5, No 3 (2013), Pagination: 164-165Abstract
Caesalpinia pulcherrima is an ornamental plant in many parts of India. It is also the country flower of Caribbean islands, Barbados and is depicted the queen's personal barbadrain flag. The plant is used in all types of medicine from the historical for various ailments. It is used in the treatment of jaundice, fever, pain, inflammation, colic, flatulence etc. The present study shows the various extracts of dried leaves of Caesalpinia pulcherrima for its purgative activity. The extracts at the dose level of 300mg/kg, p.o, exhibited significant (p<0.001) purgative activity in albino rats.Keywords
Caesalpinia pulcherrimaReferences
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- Puratchikody et al, Antipyretic activity of Dried leaf extract of Caesalpinia pulcherrima, Indian drugs, Nov 2000:37(11)551- 552.
- Evaluation of Acute and Subacute Toxicity Studies of Polyherbal Extract on Rodents
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Materials and Methods: Herbs were mixed equal in proportion and extracted with ethanol. The acute and subacute toxicity studies on ethanolic extract of were carried out to evaluate the safety on rodents. Study on acute toxicity of the ethanolic extract was found to be safe at the dose of 2000 mg/kg body weight orally as per OECD guideline No.423. General behaviour adverse effects and mortality were determined for upto 14 days. In the subacute study, the extract was administered orally at doses of 100, 200 and 400 mg/kg once in a week for 6 weeks to rats. Biochemical, haematological and histological parameters were determined after 6 weeks.
Results: In the acute study there was no toxicity/death was observed at the dose of 2000 mg/kg body weight. The onset of toxicity and signs of toxicity was also not there. In subacute study, no significant treatment related changes in the levels of haematological, hepatic and renal parameters were observed at the end of the study. It suggests that the polyherbal ethanolic extract does not appear to have any significant toxicity. Hence, the extract was safe without any toxic symptoms and signs can be further used for the pharmacological screening of antidepressant action based upon the traditional knowledge and usage.
Authors
Affiliations
1 Department of Pharmacology, Teegala Krishna Reddy College of Pharmacy, Medbowli, Meerpet, Saroor nagar (M), Hyderabad-97, IN
2 RVS College of Pharmaceutical Sciences, Sulur, Coimbatore-641404, IN
1 Department of Pharmacology, Teegala Krishna Reddy College of Pharmacy, Medbowli, Meerpet, Saroor nagar (M), Hyderabad-97, IN
2 RVS College of Pharmaceutical Sciences, Sulur, Coimbatore-641404, IN
Source
Research Journal of Pharmacology and Pharmacodynamics, Vol 6, No 2 (2014), Pagination: 94-100Abstract
Background: Cycas circinalis (flowers), Artemisia absinthium (whole plant) and Nardostachys jatamansi (rhizomes) were used traditionally for various ailments, curing diseases and majorly in CNS disorders in the treatment of antidepressant. The objective of this study was to investigate the toxicity of the ethanolic extract of selected herbs on rodents and to screen its antidepressant action in further research.Materials and Methods: Herbs were mixed equal in proportion and extracted with ethanol. The acute and subacute toxicity studies on ethanolic extract of were carried out to evaluate the safety on rodents. Study on acute toxicity of the ethanolic extract was found to be safe at the dose of 2000 mg/kg body weight orally as per OECD guideline No.423. General behaviour adverse effects and mortality were determined for upto 14 days. In the subacute study, the extract was administered orally at doses of 100, 200 and 400 mg/kg once in a week for 6 weeks to rats. Biochemical, haematological and histological parameters were determined after 6 weeks.
Results: In the acute study there was no toxicity/death was observed at the dose of 2000 mg/kg body weight. The onset of toxicity and signs of toxicity was also not there. In subacute study, no significant treatment related changes in the levels of haematological, hepatic and renal parameters were observed at the end of the study. It suggests that the polyherbal ethanolic extract does not appear to have any significant toxicity. Hence, the extract was safe without any toxic symptoms and signs can be further used for the pharmacological screening of antidepressant action based upon the traditional knowledge and usage.
Keywords
Cycas circinalis, Artemisia absinthium, Nardostachys jatamansi, Acute and Subacute Toxicity, Biochemical, Haematological, Histological, Ethanolic Extract.References
- Kessler RC, Soukup J, Davis RB, Foster DF, Wilkey SA, Rompay MIV and Eisenberg DM, The use of complementary and alternative therapies to treat anxiety and depression in the united states, Am J Psychiatry 2001; 158:289-294.
- Newberne PM Biologic effects of plant toxins and aflatoxins in rats. J Natl Cancer Inst. 1976; 56; 3:551-5.
- Campbell ME, Mickelsen O, Yang MG, Laqueur GL, Keresztesy JC Effects of strain, age and diet on the response of rats to the ingestion of Cycas circinalis. J Nutr. 1966 Jan; 88; 1:115-24.
- Moawad A, Hetta M, Zjawiony JK, Jacob MR, Hifnawy M, Marais JP, Ferreira D et al Phytochemical investigation of Cycas circinalis and Cycas revoluta leaflets: moderately active antibacterial biflavonoids, Pharm Biol. 2011; 49;12:1216-23.
- Bora KS, Sharma A. Evaluation of antioxidant and free-radical scavenging potential of Artemisia absinthium. Pharm Biol. 2011; 49; 12:1216-23.
- Yildiz K, Basalan M, Duru O, Gokpinar S Antiparasitic efficiency of Artemisia absinthium on Toxocara cati in naturally infected cats. Turkiye Parazitol Derg. 2011; 35; 1:10-4.
- Amat N, Upur H, Blazekovic B In vivo hepatoprotective activity of the aqueous extract of Artemisia absinthium L. against chemically and immunologically induced liver injuries in mice. J Ethnopharmacol. 2010; 131; 2:478-84.
- Lachenmeier DW Wormwood (Artemisia absinthium L) - A curious plant with both neurotoxic and neuroprotective properties? J Ethnopharmacol. 2010; 131; 1:224-7.
- Wake G, Court J, Pickering A, Lewis R, Wilkins R, Perry E CNS acetylcholine receptor activity in European medicinal plants traditionally used to improve failing memory. J Ethnopharmacol. 2000; 69; 2:105-14.
- Prabhu V, Karanth KS, Rao A Effects of Nardostachys jatamansi on biogenic amines and inhibitory amino acids in the rat brain. Planta Med. 1994; 60; 2:114-7.
- Lyle N, Gomes A, Sur T, Munshi S, Paul S, Chatterjee S, Bhattacharyya D The role of antioxidant properties of Nardostachys jatamansi in alleviation of the symptoms of the chronic fatigue syndrome. Behav Brain Res. 2009; 202; 2:285-90.
- Shah J, Goyal R investigation of neuropsychopharmacological effects of a polyherbal formulation on the learning and memory process in rats. J Young Pharm. 2011; 3; 2:119-24.
- Dhingra D, Goyal PK Inhibition of MAO and GABA: probable mechanisms for antidepressant-like activity of Nardostachys jatamansi DC in mice. Indian J Exp Biol. 2008; 46; 4:212-8.
- Kulkarni SK. Hand book of Experimental Pharmacology. Vallabh Prakashan; Delhi 1999. p. 29- 42.
- C. Morpurgo, Arzneim, Forsch. Drug Research. 21st Edtn. 1971. p.1727.
- Rasheed AS, Venkataraman S, Jayaveera KN, Fazil AM, Yasodha KJ, Aleem MA, Mohammed M, Khaja Z, Ushasri B, Pradeep HA, Ibrahim M. Evaluation of toxicological and antioxidant potential of Nardostachys jatamansi in reversing haloperidol-induced catalepsy in rats. Int J Gen Med. 2010; 26; 3:127-36.
- Olson H, Betton G, Robinson D. Concordance of toxicity of pharmaceuticals in humans and in animals. Regulatory Toxicology and Pharmacology. 2000; p. 56-57.
- Tomlison TR, Akerele O. Medicinal Plants their Role in Health and Biodiversity, University of Pennysylvania Press, Philadelphia, 1998; p. 286-289.
- Roberts M. Indigenous Healing Plants, Southern book, South Africa, 1990; p. 197-199.
- Rao VS, Rao A, Karanth KS. Anticonvulsant and neurotoxicity profile of Nardostachys jatamansi in rats. J Ethnopharmacol. 2005; 102; 3:p. 351-356.
- Rasheed AS, Venkataraman S, Jayaveera KN, Fazil AM, Yasodha KJ, Aleem MA, Mohammed M, Khaja Z, Ushasri B, Pradeep HA, Ibrahim M. Evaluation of toxicological and antioxidant potential of Nardostachys jatamansi in reversing haloperidol-induced catalepsy in rats. Int J Gen Med. 2010; 3:127-36.
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- Pharmacognostical and Pharmacological Evaluation of the Polyherbal Extract on Rodents
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Authors
A. Tamil Selvan
1,
R. Suthakaran
1,
B. Karun Kumar
1,
R. Naveen Kumar
1,
M. Naveena Mala
1,
D. Jai Ram
1,
M. Praveen
1
Affiliations
1 Department of Pharmacognosy, Teegala Ram Reddy College of Pharmacy, Meerpet, Saroor Nagar (M), Hyderabad, IN
1 Department of Pharmacognosy, Teegala Ram Reddy College of Pharmacy, Meerpet, Saroor Nagar (M), Hyderabad, IN
Source
Research Journal of Pharmacognosy and Phytochemistry, Vol 6, No 2 (2014), Pagination: 80-83Abstract
Hyperlipedemic is the greatest risk factor for coronary heart diseases. It is characterized by elevated serum total cholesterol, low density lipoprotein, very low density lipoprotein and decreased high density lipoprotein levels. Methanolic extract of Terminalia arjuna (bark), Phyllanthus emblica (fruits), Withania somnifera (leaves), Convolvulus pluricaulis (whole plant), Piper betle (leaves), Allium sativum (bulb), Piper longum (dry fruits), Zingiber officinale (rhizomes), Tribulus terrestris (whole plant) and Cardamom (dry fruits) these herbs were tested against high cholesterol diet induced hyperlipedemic in adult albino rats. The therapeutic dose is calculated as 200mg/kg as per the toxicity guidelines OECD 423. Fenofibrate 65mg/kg is used as a standard drug. The methanolic extracts shows a significant decrease in the levels of serum cholesterol, Triglycerides, LDL, VLDL and significant increase in the level of serum HDL against high cholesterol diet induced hyperlipedemic rats. The results shows that the polyherbal extract possess significant (p<0.001) antihyperlipedemic activity suggesting the potential role in coronary artery disease and in hyperlipidemia.Keywords
Antioxidant, Polyherbs, Hyperlipidemia, High Cholesterol Diet, Methanolic Extract.- Anxiolytic Effect of Polyherbal Extracts on Rodents
Abstract Views :174 |
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Authors
Affiliations
1 Department of Pharmacology, Teegala Krishna Reddy College of Pharmacy, Meerpet, Hyderabad, Andhra Pradesh, IN
2 RVS College of Pharmaceutical Sciences, Sulur, Coimbatore, Tamil Nadu, IN
1 Department of Pharmacology, Teegala Krishna Reddy College of Pharmacy, Meerpet, Hyderabad, Andhra Pradesh, IN
2 RVS College of Pharmaceutical Sciences, Sulur, Coimbatore, Tamil Nadu, IN
Source
Research Journal of Pharmacognosy and Phytochemistry, Vol 7, No 1 (2015), Pagination: 1-5Abstract
Background: Anxiety, unlike other psychiatric conditions such as schizophrenia or depression, is both an emotional and a psychiatric disorder. It commonly co-exists with other clinical conditions but can be diagnosed on the basis of symptoms and course of the disease.
Objective: To study the anxiolytic activity of polyherbal extract and to estimate the biogenic amines.
Materials and Methods: The anxiolytic effect of polyherbal extracts containing Leptadenia reticulata ischolar_mains (Asclepiadaceae), Mimusops elengi bark (Sapotaceae) and Evolvulus alsinoides Whole plant (Convolvulaceae) were studied in rodents. Different animal models like elevated plus maze, stair case, and mirrored chamber were used for assessing the anxiolytic property of the polyherbal extracts.
Results: The results revealed that ethanolic and acetone extract at the dose of 200mg/kg significantly produced anxiolytic action, in a same way to that of diazepam (2mg/kg, p.o) standard drug, along with significant entries responses in all the above experimental models used. Polyherbal extracts showed significant (p<0.001) decreases in serotonin and norepinephrine in the whole brain of rat. The dopamine level was significantly (p<0.001) increased by the extracts. The extracts might potentially act by increased GABAnergic activation and/or by modulating the serotoninergic levels in the central nervous system.
Conclusion: Traditional system of medicine using herbs in neuro disorders exhibit potent anxiolytic action in the above study.
Keywords
Leptadenia reticulata, Mimusops elengi, Evolvulus alsinoides, anxiolytic, Polyherbal, Diazepam.- The Wound Healing, Anti Inflammatory and Haemostatic Effect of Eupatorium odoratum
Abstract Views :177 |
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Authors
Affiliations
1 Department of Pharmacology, R.V.S. College Pharmaceutical Science, Sulur, Coimbatore-640 402, IN
1 Department of Pharmacology, R.V.S. College Pharmaceutical Science, Sulur, Coimbatore-640 402, IN