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DIRECTLY COMPRESSIBLE TASTE MASKED "MEDICATED CHEWING GUM


(MCG)" FOR STAYING ALERT @ CRS- Mumbai, Indian Chapter.

Conference Paper · February 2010

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Shivang Chaudhary
National Institute of Pharmaceutical Education and Research
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FACTORIAL DESIGN FOR FORMULATION DEVELOPMENT OF
DIRECTLY COMPRESSIBLE TASTE MASKED “MEDICATED
CHEWING GUM (MCG)” FOR STAYING ALERT
SHIVANG CHAUDHARY 1, VINEET PATEL2, MANJU MISRA1, ALIASGAR SHAHIWALA 1
1 National Institute of Pharmaceutical Education & Research (NIPER) – Ahmedabad, C/o 2B.V.Patel PERD center,

S.G.Highway, Thaltej, Ahmedabad, Gujarat, India. Email:shivaniper@gmail.com AHMEDABAD

INTRODUCTION &
OBJECTIVES
ALERT CHEWING GUM FORMULATION
DEVELOPMENT
FORMULATION EXCIPIENTS A (%) B(%) C(%) D(%) E (%) F(%)
GUM BASE HEALTH IN GUM®
55 60 65 70 75 80
CCG resolve
same purpose of DRUG Caffeine anh. 10 10 10 10 10 10
Chewing
Caffeine is a staying alert ANTIADHESIVE + 1.TALC 25 20 15 10 5 0
action itself
CNS stimulant, from both sides FILLER 2.Maltitol 25 20 15 10 5 0
enhances 25% 3.Sorbitol 25 20 15 10 5 0
used in one from drug
blood flow to 4.Maltodextrin 25 20 15 10 5 0
management (caffeine) &
the brain LUBRICANT 1.Mg stearate 2 2 2 2 2 2
of fatigue & another from
resulting in 2.POLY-OH strt 2 2 2 2 2 2
increasing Drug delivery
improvement 3.PEG 4000 2 2 2 2 2 2
alertness system(chewing 4.PEG 6000 2 2 2 2 2 2
in alertness
gum) itself. GLIDANT 1.CORN STARCH 1 1 1 1 1 1
2.Aerosil 1 1 1 1 1 1
3.Cab- o- sil 1 1 1 1 1 1
4.Syloid 1 1 1 1 1 1
Objectives: To develop:- SWEETENER 1.ASPARTAME 5 5 5 5 5 5
2.Sucralose 5 5 5 5 5 5
1. Directly compressible TM CCG 3.Saccharin 5 5 5 5 5 5

2. Release sufficient amount of 4.Sucrose


1.CARDAMOM OIL
5 5 5 5 5 5
FLAVOR 2 2 2 2 2 2
caffeine in few minutes of 2.Cinnamon oil 2 2 2 2 2 2
3.Clove oil 2 2 2 2 2 2
chewing for quick action. 4.Peppermint oil 2 2 2 2 2 2

32 FACTORIAL
DESIGN

%DRUG RELEASE = +88.33 + 5.67A


- 1.50B + 0.25 AB - 2.00A²- 0.50B²

PERFORMANCE
RESULTS
EVALUATION

PARAMETERS RESULT WITH INDICATION


Each person CHEWED one sample of the chewing
Angle of repose 30.46° -Very good as per EP
gum for different time periods (2, 5, 10, 15, 20 min).
Carr’s index 13.99 -Very good as per EP
Uniformity of 99.02% (98.5-101.5%)–
The residual gums have been CUT into small pieces, FROZEN
content Passes as per EP
& then GROUND till obtaining a fine powder. %weight loss in 0.30% (<1.00%) – Passes
Friability as per EP
The residual drug content was determined. %caffeine release in 91.68% - Acceptable (Predicted
QUALITY 15 minutes release was 91.50% as per contour
plot within 15 minutes of chewing)
EVALUATION ACTUAL DRUG CONTENT
Taste score 3.91 / 5.00 - Very good
RESIDUAL DRUG CONTENT

Sample Acceptance Result RELEASED CONCLUSION


taken criteria DRUG CONTENT
20 units NMT 1 No one is UNIFORMITY
±5.00% deviating OF MASS
From the result it was concluded that directly compressible
MCG triturated &
dispersed in 250ml of
Medicated Chewing Gum of caffeine present a widely acceptable
Initial Final %Weight
wt of wt. of Loss in water:methanol better patient compliant alternative to any other dosage form.
10 MCG 10 MCG Friability %WEIGHT
LOSS IN
UNIFORMITY (70:30)
OF CONTENT
FRIABILITY

Sonicated for 1 hr with


REFERENCES
10gm 9.97g 0.3%
Continuous heating
Sample Theoratical Experimental %Uniformity 1. Jacobsen, Christrup L.L MCG: Pros and Cons. ,Am.J.Drug Del ,2, 04,75-88.
taken Content Recovery of content Centrifuged 2. Wilson & Gisvold's textbook of organic Medicinal & pharmaceutical chemistry, 511-512
03 400ug/ml 396.10ug/ml 99.02% Supernatant analyzed 3. www.chewinggumfacts.com
4.European pharmacopoeia,2.9.5.,2.9.6,2.9.7,2.9.25.,2.9.36,6thedition.

CONTROLLED RELEASE SOCIETY ,10th INTERNATIONAL SYMPOSIUM ON ADVANCES IN TECHNOLOGY


& BUSINESS POTENTIAL OF NDDS, 2010, MUMBAI, INDIA.
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