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[AJPSci.] Asian J. Res. Pharm. Sci. 2013; Vol. 3: Issue 3, Pg 114-116 ISSN- 2231–5640 (Print) ISSN- 2231–5659 (Online) www.asianpharmaonline.org RESEARCH ARTICLE Evaluation of few Marketed products of Salbutamol sulphate syrup IP Girish Pai K.*, Vamshi Krishna T., Lalit Kumar, M. Sreenivasa Reddy, Shreya Singh and Vibha V. Department of Pharmaceutics, MCOPS, Manipal University, Manipal, Karnataka-576104 *Corresponding Author E-mail:- [email protected] ABSTRACT The objective of the study was to assess whether few marketed brands of Salbutamol sulphate syrup IP was within the limits as specified in Indian Pharmacopoeia with respect to selected physical parameters. A study was carried out using two different brands coded as brand A and B for Salbutamol sulphate syrup IP. In this study, selected brands were well known brands and a comparative study was planned. Salbutamol is a short acting β2 adrenergic receptor agonist used commonly for the relief of bronchospasm in conditions such as asthma and Chronic Obstructive Pulmonary Disease (COPD). In the present study, three different batches each of brand A and brand B were procured randomly from the medical shop. The tests that were performed included the visual inspection or appearance of product, pH measurement, extractable volume, primary labeling quality and checking of text matter on primary label. From the study, it was found that both the brands were comparable with respect to various physical parameters; however brand B was chosen as best since the results for all three batches were consistent and uniform. Brand A was not user friendly since there was difficulty in opening cap as it is uncomfortable for a patient suffering from asthma. These types of problems sometimes receive market complaints as well. KEYWORDS: Salbutamol sulphate, COPD, extractable volume, text matter. INTRODUCTION: Salbutamol is a short acting β2 adrenergic receptor agonist used for the relief of bronchospasm in conditions such as asthma and COPD. Chemical structure of Salbutamol is represented below, Salbutamol is used to prevent and relieve bronchospasm in patients with reversible obstructive airway disease and exercise induced bronchospasm. It’s off label uses are hyperkalemia with renal failure and preterm labor management.4 The most common side effects of this drug include headache, insomnia, hypertension and tachycardia. Other side effects include tooth discoloration, hypersensitivity reaction and paradoxical bronchospasm.4 It is available in various dosage forms like tablet, syrup, metered dose inhaler (MDI), dry powder inhaler (DPI), Chemical formula: C13H21NO3 nebulised solution and intramuscular or intravenous injection that may be given as following dosage strengths. Its IUPAC name is (RS)-4-[2-(tert-butylamino)-1- The usual dose of oral salbutamol is 2 to 4 mg three times a hydroxyethyl]-2-(hydroxymethyl) phenol.5 day for adult and 1 to 2 mg three times a day for children.4 Received on 16.05.2013 Accepted on 10.07.2013 © Asian Pharma Press All Right Reserved Asian J. Res. Pharm. Sci. 2013; Vol. 3: Issue 3, Pg 114-116 Syrups are concentrated aqueous preparations of a sugar or sugar substitute with or without flavoring agents and medicinal substances. These are intended to serve as pleasant tasting vehicles for medicinal substances to be added in the extemporaneous compounding of prescriptions or in the preparation of medicated syrup, which is a syrup 114 [AJPSci.] Asian J. Res. Pharm. Sci. 2013; Vol. 3: Issue 3, Pg 114-116 containing therapeutic agents. Syrups contain a sugar, usually sucrose, or sugar substitute used to provide sweetness and viscosity. Antimicrobial agents in the form of preservatives are also added flavors to give flavor to the syrup and colorants to give a pleasing appearance. Many types of syrup especially those prepared commercially contain special solvents, solubilising agents, thickeners or stabilizers.2 The objective of the study was to check whether the commercial Product was within the limits as specified by IP. In this study two brands A and B were compared. In the present research work, 3 batches each of brand A and brand B were taken. MATERIALS AND METHODS: RESULTS AND DISCUSSION: Brand A was in amber glass bottle. Out of the three batches, two opened easily but the other one had to be opened with a knife. The product was available in sunset yellow color as specified under Drug and Cosmetics Act. There was foaming seen in the bottle without shaking. Labeling included the manufacturer’s name, manufacturing and expiry date, precautions for handling and storage, as it is a Schedule H drug the warning was also mentioned. The different tests were carried out as mentioned above. The solution was found to be clear; there was no presence of fiber content or foreign particles. The density was found to be same for all the three batches of brand A. pH was measured and it was within the limits as specified in IP. The extractable volume for two batches was found to be more than as claimed by the label. Materials: For the present work, Salbutamol sulphate syrup IP of 100 ml pack size was procured randomly from Brand B was available in amber colored plastic bottle pharmacy outlets, pH meter, white paper, magnified lens etc provided with a dosing cup. The three batches could be opened easily without much force. The product was Methods: The experimental methods that were carried out available in carmoisine color as specified under Drug and including visual inspection, appearance, pH measurement, Cosmetics Act. There was no foaming seen with any of the extractable volume, primary labeling quality and checking three batches. Labeling included the manufacturer’s name, of text matter on primary label.1 manufacturing and expiry date, precautions for handling and storage was not specified on any of the batches, as it is Visual inspection: Visually the container and closure were a Schedule H drug the warning was also mentioned. The inspected using a magnified lens and a white background. different tests were carried out as mentioned above. The The color that was added to the solution was checked solution was clear; there was no presence of fiber content or whether its use is permitted under the Drugs and Cosmetics foreign particles. In the measurement of extractable volume, Act. The common name and the percentage of the color two batches were found to be within the volume as claimed whether it was stated on the container were also noted. by the label. The label of the container was checked. The identity of drug and its manufacturer, manufacturer’s name, address, license number and batch number was checked. The potency, standard, grade, dose etc. expressed in milliliters was noted. Manufacturing and expiry dates were noted down. The precautions for handling, storage, sale/usage etc. were also checked. As it is a Schedule H drug the “Warning: To be sold on the prescription of a Registered Medical Practioner only” was also checked.3 Appearance: The clarity of three batches of brand A and brand B was checked visually. This was done by pouring the syrup in a clean and dry beaker and observing it against white and black backgrounds. With magnifying lens it was checked for the presence of fiber content and whether the product had foreign particles was also checked. Table 1: GENERAL PARAMETERS* PARAMETERS Brand A Brand B Color Sunset yellow Carmoisine red Container Amber colored Amber colored plastic glass container container Foam formation Present Absent without shaking Foam formation Present Absent on shaking Labeling Storage conditions Storage conditions and and warning was warning was not mentioned on the mentioned on the label label *Tests performed for information purpose only pH measurement: The pH of syrup was determined potentiometrically by means of a glass electrode and a reference electrode using a calibrated pH meter. The pH meter was calibrated using standard buffer solutions before measuring the pH of syrup. pH limit as per IP is 3.4 to 4.5. 6 Extractable volume: The solution was poured in a clean and dry 100mL calibrated measuring cylinder and the volume was found to be not less than 100 mL as stated on label. Figure – 1: Graph for pH 115 [AJPSci.] Asian J. Res. Pharm. Sci. 2013; Vol. 3: Issue 3, Pg 114-116 6. Table 2: pH comparison, IP limit is 3.4 to 4.5. Bottle No Brand A 1 3.62 2 3.59 3 3.59 Brand B 3.52 3.52 3.5 Table - 3: Extractable volume Bottle No Brand A 1 2.5 2 2 3 1.9 Brand B 2 2 Figure -2 : Graph for extractable volume CONCLUSION: Out of the three batches of Brand A, two bottle could be opened with difficulty. There was foaming seen without shaking. The text matter on label was in line with Drugs and Cosmetics act. The results of the tests performed were found to be within the limits. Out of three batches of Brand B, all could be opened easily. There was no foaming seen with or without shaking. The label did not specify the storage condition and warning as under Drugs and Cosmetics Act. The results of the tests performed were found to be within the limits. From the study, it was found that both the brands were comparable with respect to various physical parameters; however brand B was chosen as best since the results for all three batches were consistent and uniform. Brand A was not user friendly since there was difficulty in opening cap as it is uncomfortable for a patient suffering from asthma. These types of problems sometimes receive market complaints as well. REFERENCES: 1. 2. 3. 4. 5. General chapters – Dosage forms, Indian Pharmacopoeia, 2007, 5th ed., Vol 2, p.38. Lyod. V. Allen, Nicholas. G. Povovich, Howard .C. Ansel. Solutions. In: Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems.8th ed. Philadelphia: Lippincott William and Wilkins; 2005. Drugs and Cosmetics Act 1940. www.cdsco.nic accessed on 16th April, 2013. http://salbutamol.org/ accessed on 16th April, 2013. http://en.wikipedia.org/wiki/Salbutamol accessed on 16th April, 2013. 116 Salbutamol syrup, 2007, 5th ed., Indian Pharmacopoeia, Volume 3, Ghaziabad: Ministry of Health and Family welfare, Government of India, pp. 1065.