Volume-6, Issue-2, April-2015

Available Online at www.ijppronline.in

FORMULATION AND STABILIZATION OF

Anil Hooda*1, Pawan Jalwal2, Balvinder Singh2, Upma2 ISSN NO:0976-6723

1.Department of Pharmaceutical Education and Research, BPSMV, South Campus, Sonepat, Haryana
2.Shri Baba Mast Nath Institute of Pharmaceutical Science and Research, Asthal Bohar, Rohtak,Haryana
Abstract
Formulation scientist in the present pharmaceutical industry faced a lot of problems regarding stability of the
liquid formulation as some of the active compounds having some problem in dissolving, showing
precipitation when exposed to stability studies. In the present study performed on Bromhexine orals syrup as
having stability issue that it becomes turbid exposure to a accelerated stability studies so to overcome this
problem Malic acid was used to stable this formulation.
Keywords: - Formulation, Physicochemical properties, Accelerated Stability study.
Introduction Materials and Methods
Stability in pharmaceutical formulation is critical as Bromhexine Hydrochloride was procured as a gift
well as basic parameters. The oral use of liquid sample from Ratchet Lab, Limited. Other excipients
pharmaceuticals has generally been justified on the were purchased from S.D fine chemicals.
basis of ease of administration to those individuals Methods
who have difficulty in swallowing solid dosage forms. 1. Preparation of Base: -
With rare exceptions, a drug must be in solution in  Take 30 ml Purified water. Add sugar and heat
order to be absorbed. A drug administered in solution up to 80-90 degree with continuous stirring until
is immediately available for absorption, and in most get clear and cool up to 40 degree.
cases, is more rapidly and efficiently absorbed than  Add Sorbitol and Glycerin into step no 1 with
the same amount of drug administered in a tablet or continuous stirring to get a clear solution.
[1, 2]
capsule.  Take 100ml purified water and dissolve Sodium
Bromhexine is an oral mucolytic agent with a low methyl paraben, Sodium propyl paraben,
level of associated toxicity. Bromhexine acts on the Sucralose with continuous stirring to get a clear
mucus at the formative stages in the glands, within the solution and add into step no 1.
mucus-secreting cells. Bromhexine disrupts the 2. Preparation of Drug Solution: -
structure of acid mucopolysaccharide fibres in mucoid  Take Propylene Glycol and heat up to 50 Degree
sputum and produces less viscous mucus, which is with continuous stirring until get clear. Cool the
easier to expectorate. [3] solution to room temperature.
 Dissolve Malic Acid in Purified water and add in
to step no 1 with continuous stirring and check
the clarity of the solution.
3. Add Step no 2.0 into step no 1.0 with continuous
stirring and check the clarity of the solution.
4. Addition of Colors:- Dissolve Colour into purified
water and add into step no 1 with continuous stirring
Human skin Figure No 1: - Chemical Structure of and add into step no 1.
Bromhexine Hydrochloride 5. Addition of Flavors: - Add Flavour into Step no 1

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with continuous stirring. Formulation of Stabilized Syrup
6. Adjustment and Volume make up: - Dissolve Malic A series of formulations were prepared as given in
acid in purified water and adjust pH in the range of table 1 with various concentrations of excipients and
4.0-4.5 and volume was making up with purified were evaluated for stability, pH, Clarity. F1 to F4
water. formulation were formulated by using different
excipients.
Table No 1: - Formulation of Stabilized Syrup

Use of Excipients in Formulation

Table No 3: - Result of physically parameter of developed stabilized syrup

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Table No 4: - Stability studies through Physicochemical Parameters

Evaluation of Developed Oral Stabilized the normal time that they would remain in stock and
Formulation in use. Such approach was time consuming. Now a
1. Color examination: - Five ml final syrup was day’s Accelerated stability studies are used by most
taken into watch glasses and placed against white of the pharmaceuticals for stability evaluation of all
back ground in white tube light. It was observed types of formulations. [4] In four formulation from F1
for its color by naked eye. to F4. F3 will be the best formulation that observed
2. Odor examination: - Two ml of final syrup was after accelerated study on the basis of clarity, odor,
smelled individually. The time interval among taste and pH.
two smelling was kept 2 minutes to nullify the Conclusion
effect of previous smelling. In conclusion, stabilized formulation of Bromhexine
3. Taste examination: - A pinch of final syrup was syrup prepared in the laboratory scale may be used as
taken and examined for its taste on taste buds of a stable liquid dosage form and the results of the
the tongue. accelerated stability study will help in justifying the
4. Determination of pH: - pH of the suspension stability of the formulation in future.
was determined by the use of Metler Toledo pH References:
meter. 1.Lachman L, Lieberman HA, Kanig JL. The Theory
Accelerated Stability Study and Practice of Industrial Pharmacy. 3rd ed.,
F1 to F4 oral syrup formulation were packed in 100 Bombay; Varghese Publishing House: 1987.
ml Amber color pet bottle. The packed bottles were 2.Ansel HC, Allen LV. Pharmaceutical dosage form
placed in stability chamber maintained at 40 + 2 °C and drug delivery systems. 7th ed., Lippincott: 2000.
and 75 + 5% RH for 3 month. Samples were 3.Giriraj P et al “Reverse Phase Hplc Method for the
collected at days 0, 30, 60 and 90. The analyses Simultaneous Estimation of Terbutanile Sulphate,
comprised chemical testing of quantifiable Bromhexine Hcl and Guaifenesin in Cough Syrup.
parameters, which could possibly change during storage, Asian Journal of Pharmaceutical and Clinical
such as Colour, pH, drug contents, taste and odor. Research. Volume 4, Issue 2.
Result 4.Trivedi P, Sachan A, Two spectrophotometric
In the past it was the practice in many methods have proposed for simultaneous analysis of
pharmaceutical manufacturing companies to evaluate bromhexine hydrochloride, diphenhydramine
the stability of pharmaceutical preparations by hydrochloride and Guaiphenesin from multi component
observing them for a year or more, corresponding to syrup formulation. Indian drugs 1999; 36, 735‐738.

Correspondence Address:
Anil Hooda
Department of Pharmaceutical Education and Research,
BPSMV, South Campus, Sonepat, Haryana
E-mail- [email protected]
Phone: +919416373675

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