Professional Documents
Culture Documents
Schwarzenbek
November 15th – 16th
Marc Ribé
Project Mgr Pharma Business
CAFOSA
Index
Probiotic Gum
Energy Gum
Patient compliance
Fast onset of action of the drug
New Pharmaceutical Developments
Line Extensions of existing products
Specific Age Categories: Teenagers, Children
Probiotic Gum:
Developed in Japan by Kracie Foods Ltd.
Energy Gum
1.0E+10
1.0E+09
LAB (CFU/g)
1.0E+05
1.0E+04
0 1 2 3 4
Treatment time (week)
The 1st clinical study: improvements in saliva status and gum status
Test method:
Grouping: 1) Placebo group (LAB non-contained) and 2) Test group (LAB contained)
1st examination: Ingestion of Gum piece after meals during 4 weeks
2nd examination: After 4 more weeks without use of Gum
Test parameters:
number of harmful bacteria in saliva, clinical value of gum status
Test schedule:
Start ingestion Finish ingestion End of test
Basic
examination (1st examination) (2nd examination)
The 1st clinical study: improvements in saliva status and gum status
Showed significant decrease of total bacteria count in saliva by ingesting LAB
contained HiG for 4 weeks
◆Placebo
cells/ml
■Test
1.0E+07
* :P<0.05
Decrease
1.0E+06
weeks
The 1st clinical study: improvements in saliva status and gum status
Showed significant decrease of Porphyromonas gingivalis count in saliva by
ingesting LAB contained HiG for 4 weeks
1.0E+04
◆Placebo
cells/ml
■Test
1.0E+03
1.0E+02
* :P<0.05
1.0E+01
Decrease weeks
※P.g:, major periodontal pathogen
© Cafosa Gum S.A.U. – all rights reserved
Probiotic Gum (by Kracie Foods Ltd.)
Brief overview:
Ingestion of lactobacillus contained HiG for 4 weeks, and counted numbers of
bacteria and clinical value before and after intake
Measure results
Showed significant decrease of RED COMPLEX※ count in saliva by ingesting
LAB contained HiG for 4 weeks
T. denticola
week 0 4 significant difference
T. forsythensis
week 0 4 significant difference
Conclusions
Probiotic Gum
Energy Gum:
Developed in India by the National Institute of Pharmaceutical
Education & Research (NIPER)
Parameters measured:
Uniformity of Mass: 0.3%<5.00% - acceptable
Uniformity of content of optimized formula: 99.21% (98.5-101.5%)
– passes as per EP
%weight loss in Friability test: 0.14% (<1.00%) – passes as per EP
Residual gum cuds are cut into small pieces, frozen and ground till obtaining
fine powder. Then they are analyzed to determine residual drug content by UV
visible spectrophotometer at 273 nm.
Energy gum
B:
am
He ount
alth of
in G
um
Conclusions
9 Viability of formulation
Probiotic Gum
Energy Gum
Credits
By Shivang Chaudhary
Department of Pharmaceutics
Niper, Ahmedabad
Study performed
1. Preformulation Study
2. Formulation Design
3. Quality Evaluation of Medicated Chewing Gum
4. Performance Evaluation of Medicated Chewing Gum
5. Evaluation of Factors affecting Drug Release from Medicated
Chewing Gum
Complete Formula
Optimized Formula of CTZ-MCG by Direct compression method
Category Drug or Excipients in mg. in %
Gum powder Health In Gum 1162.4 mg (83.00%)
Results Of Official Product Quality Assessment Tests
Sr No. Official Tests Observations Compliance criteria Result
Out of 20 MCG;
01 Uniformity of Mass NMT 2 deviate from ±5% Pass
none deviated from ±5%
all 10 MCG contain CTZ
02 Uniformity of Content 95% < x < 105% Pass
within limits
total weight loss =
03 Friability testing Weight loss< 1.00% Pass
0.07% of 10 MCG
Analysed by UV spectrophotometer at
230.4 nm to determine residual drug
content in MCG
Release after:
F B
1 minute
2 minutes
5 minutes
10 minutes
15 minutes
E C
f
ount o
m
B: a in Gum
lth
Hea
Conclusion
9 Cetirizine Gum has passed all official MCG Quality tests including
uniformity of mass, assay for uniformity of content & Friability testing as per
compliance criteria mentioned in official monograph of MCG in EP
Presentation Publication
Thank you