Jain B V et al IJARPB: 2013, 3(2), 80-83 ISSN: 2277-6222
Available online on www.ijarpb.com
Research Article
Received on 15/01/2013; Revised on 23/01/2013; Accepted on 27/01/2013;
FORMULATION AND DEVELOPMENT OF TASTE MASKED AMBROXOL HYDROCHLORIDE
SUSPENSION USING ION EXCHANGE RESINS
Bharat V. Jain*1, Dr. Shashikant D. Barhate2
1 Ph.D. Research Scholar, JJT University, Jhunjhunu, Rajasthan
2 Shri Sureshdada Jain Inst. of Pharmaceutical Education and Research, Jamner, M.S
Email: bharatjain2006@gmail.com
ABSTRACT
In the present work the attempt was made to prepare taste masked suspension of Ambroxol
Hydrochloride by abating the intensely bitter taste of Ambroxol Hydrochloride. Taste abatement was
done by complexing of Ambroxol hydrochloride with different Ion Exchange Resins (IER) like Tulsion
335 and Indion 214 in different ratios. The prepared suspensions were evaluated for taste, drug
content, particle size, viscosity, sedimentation volume and drug release. The resonates prepared with
drug- T335 ratio (1:2) at pH 8, gave maximum drug loading. Suspension containing above resinates
showed more than 80% In vitro drug release within 30 min. Prepared formulation also showed good
stability and can retain its palatable taste. The developed formulation was an additional advantage like
simplification of manufacturing procedure and is economical. Thus, the “patientfriendly dosage form” of
bitter drugs, especially for pediatric, geriatric, bedridden, and noncooperative patients, can be
successfully formulated using this technology.
KEYWORDS: AHS, Formulation, IER, Taste masking.
INTRODUCTION resin complex formed is such that the average
Children are frequently failed to take pH of 6.7 and cation concentration of about
medications properly because of unpleasant 40meq/L in the saliva are not able to break the
taste of medicament. Non‐compliance can lead drug resin complex but it is weak enough to
to worsening of diseased condition1. Numbers break down by hydrochloric acid present in the
of taste masking technologies have been used stomach. Thus the drug resin complex is
to address the problem of patient compliance. absolutely tasteless with no after taste, and at
In Ion exchange resin (IER) method weak the same time, its bioavailability is not affected.
cation exchange or weak anion exchange Children under the age of 8 are typically
resins are used for taste masking, depending prescribed liquid medications because of
on the nature of drug2. The nature of the drug smaller structure of a child's esophagus3,4.
© 2011, IJARPB. All Rights Reserved 80
Jain B V et al IJARPB: 2013, 3(2), 80-83 ISSN: 2277-6222
Ambroxol HCl is a highly bitter drug, used in resins were dried overnight in hot air oven at
the treatment of respiratory disorders 500C and kept in an amber glass vial.
associated with viscid mucous5,6.
Preparation of drug – resin complex
MATERIALS AND METHODS Drug‐resin complex were prepared by batch
Materials process. Step 1: Weigh all the ingredient
Ambroxol HCl was gift sample from Alkem accurately. Now add weighted quantity of resin
Pharmaceuticals Ltd.,(Mumbai, India). Tulsion in specific quantity of water and stir it for 15
335 was obtained as gift sample from Thermax, min. under mechanical stirrer. Step 2: Now add
Pune and Indion 214 was purchased from Ion weighted quantity of Ambroxol HCl in to step 1
exchange India limited (Mumbai, India). & stir it for 4 to 5 hr. continuously under stirrer.
Sucrose, Sorbitol, Glycerine, Xanthane gum, Step 3: Take specific quantity of water boil it
Aspartame, Methyl paraben and Mangocandy dissolve sugar & filter it. Now cool the syrup at
flavour were purchased from S. D. Fine room temperature and add sorbitol and glycerin
chemicals (Mumbai, India). All other in it & add into step 2 under continuous stirring.
chemicals/solvents were of analytical grade. Step 4: Take water & add xanthane gum and
stir it to form a paste. Add this paste in step 3
Methodology slowly under stirring. Step 5: Take warm water
Purification of ion exchange resin dissolve methylparaben, propylparaben &
Resins were purified using the method reported aspartame in to it & add in to above solution
by Irwin et al1. The resins (5 g) were washed under stirring. Step 6: Now add coloring,
successively with distilled water, methanol (50 flavoring agent in step 5 & make volume of
ml), benzene (50 ml), methanol (50 ml) and suspension up to required quantity by using
several times with distilled water to eliminate purified water, pH of resin solution was
organic and color impurities. Then, the wet adjusted to 8 by using 1 M KOH.
resins were activated by 0.1 M HCl 50 ml and Preparation of Suspension
washed several times with distilled water. All Suspensions were prepared as per Table No. 1
Table No. 1: Composition of Ambroxol HCl Suspension
Complex Preparation F1 F2 F3 F4
Ambroxol HCl 100 100 100 100
Tulsion 335 100 200 - -
Indion 214 - - 100 200
Purified Water (ml) 2.5 205 2.5 2.5
Syrup preparation
Sucrose (mg) 2.25 2.25 2.25 2.25
Glycerine (ml) 0.5 0.5 0.5 0.5
Xanthan Gum (mg) 20 20 20 20
Methyl Paraben (mg) 10 10 10 10
Propyl Paraben (mg) 4 4 4 4
Asparteme (mg) 15 15 15 15
Mango Candy Flavor (ml) 0.13 0.13 0.13 0.13
Quinoline yellow color (mg) 0.1 0.1 0.1 0.1
Purified water uo to (ml) 5 5 5 5
© 2011, IJARPB. All Rights Reserved 81
Jain B V et al IJARPB: 2013, 3(2), 80-83 ISSN: 2277-6222
Evaluation of Ambroxol HCl Suspension content, viscosity, sedimentation rate, invitro
The suspensions were evaluated for dissolution etc. (Table No. 2)
physicochemical characterization like drug
Table No. 2: Evaluation Parameter of Ambroxol HCl Suspension
Parameter F1 F2 F3 F4
Appearance uniform uniform uniform uniform
Taste Sweet, palatable Sweet, palatable Sweet, palatable Sweet, palatable
pH 6.0 5.9 5.9 6.1
Viscosity (cps) 210 303 220 310
Sedimentation Ratio 0.92 0.96 0.93 0.94
Redispersibility +++ +++ +++ +++
Drug content (% w/v) 92.7 97.2 91.54 94.6
In vitro dissolution (%) 89.56 94.20 88.69 90.05
RESULT AND DISCUSSION Dissolution profile of Suspension
Prepared suspensions showed satisfactory In vitro release study was carried out in 0.1 N
physical properties. Drug content for F1, F2, F3 HCL using USP paddle apparatus at 50 rpm.
and F4 were 92.7, 97.2, 91.54 and 93.6. The release data given (Figure-I) showed that
Results shows that using Tulsion‐335 and the rate of drug release from the suspension
Indion 214 maximum drug loading were was increase as drug: resin ratio increases.
observed at 1:2 drug‐resin ratio. More than 70% of drug was released within 30
min from all formulations.
Figure 1: In vitro drug release profile of Ambroxol Hcl Suspension
CONCLUSION medicine can thwart the benefits of even the
Many parents are faced with the daily most powerful drug, and failure to consume
challenge of getting their children to take a medication may do the child harm, and in some
medicine. The unpleasant flavor of the cases, may be life‐threatening. Use of ion
© 2011, IJARPB. All Rights Reserved 82
Jain B V et al IJARPB: 2013, 3(2), 80-83 ISSN: 2277-6222
exchange resin offers superior method for 3. Isah AB, Abdulsamad A, Gwarzo MS,
preaparing taste‐masked substrates of Abbah HM. Evaluation of the
Ambroxol HCl. Results obtained in this work disintigrant properties of
show that drug‐resin complexes effectively microcrystalline starch obtained from
masked bitter taste of Ambroxol HCl. While cassava in MNZ. Nigerian Journal of
liquid formulation provides easier way to Pharmaceutical Sciences, 2009, 8, 26-
administer and getting the child to swallow. 35.
4. Schwartz R. Enhancing children’s
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© 2011, IJARPB. All Rights Reserved 83
