Download Evaluation of few Marketed products of Salbutamol sulphate syrup IP

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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
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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
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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.