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Success Stories

Schwarzenbek
November 15th – 16th

Marc Ribé
Project Mgr Pharma Business
CAFOSA
Index

ƒ Medicated Chewing Gum available today

ƒ Compressed Gum: new insights for the future

ƒ Probiotic Gum

ƒ Energy Gum

ƒ Cold Relief Gum

© Cafosa Gum S.A.U. – all rights reserved


MCG available today

Products commercially available

ƒ NRT Gum (Nicotine):


– Nicorette®, Nicotinell®, Niquitin®

ƒ Motion Sickness Gum (Meclozine, Dimenhydrinate):


– Travvel®, Dramine®, Biodramina®

ƒ Oral Care Gum (Chlorhexidine, Probiotics):


– Hexit®, ProbioticGum™

ƒ Digestive Gum (Sodium Picosulphate):


– Kritel Chicles®

ƒ Energy Gum (Caffeine):


– StayAlert®, Gum Alert

© Cafosa Gum S.A.U. – all rights reserved


Compressed Gum
New Insights for the future

The compressed gum production allows pharmaceutical companies to


adopt chewing gum as an innovative drug delivery system

ƒ Patient compliance
ƒ Fast onset of action of the drug
ƒ New Pharmaceutical Developments
ƒ Line Extensions of existing products
ƒ Specific Age Categories: Teenagers, Children

© Cafosa Gum S.A.U. – all rights reserved


Index

ƒ Medicated Chewing Gum available today

ƒ Compressed Gum: new insights for the future

ƒ Probiotic Gum:
Developed in Japan by Kracie Foods Ltd.

ƒ Energy Gum

ƒ Cold Relief Gum

© Cafosa Gum S.A.U. – all rights reserved


Probiotic Gum (by Kracie Foods Ltd.)

ƒ Compressed Gum: Formulation with HiG with Lactic Acid Bacteria


(LAB)
ƒ Survival results of Probiotic tested: optimised due to low water activity

1.0E+10
1.0E+09
LAB (CFU/g)

1.0E+08 Compressed gum (HiG)


1.0E+07 Stick gum
1.0E+06

1.0E+05

1.0E+04
0 1 2 3 4
Treatment time (week)

© Cafosa Gum S.A.U. – all rights reserved


Probiotic Gum (by Kracie Foods Ltd.)

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)

ingestion period (4 weeks) watching period (4 weeks)

© Cafosa Gum S.A.U. – all rights reserved


Probiotic Gum (by Kracie Foods Ltd.)

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

Total bacteria count in saliva


1.0E+08

◆Placebo
cells/ml

■Test
1.0E+07
* :P<0.05

Decrease
1.0E+06
weeks

© Cafosa Gum S.A.U. – all rights reserved


Probiotic Gum (by Kracie Foods Ltd.)

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

Total P.g. count in saliva


1.0E+05

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.)

The 1st clinical study: presentation of findings

Title of the study:


The Effects of an Improved Oral Environment by Lactic Acid Bacterium
Containing Gum
Findings were presented at the Japanese Society of Conservative Dentistry in
2008 and won the DENTSPLY Merit Award*

DENTSPLY Merit Award:


Academic encouraging prize in recognition
of distinctive contributions in Conservative
Dentistry

© Cafosa Gum S.A.U. – all rights reserved


Probiotic Gum (by Kracie Foods Ltd.)

The 2nd clinical study: gum improvements of periodontal disease patients

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

Presented the findings at


the Japanese Society of Conservative Dentistry in 2010

※RED COMPLEX = the three major causing bacteria for periodontal


disease: P.gingivalis, T.denticola and T.forsythensis
(with big impact to serious periodontal disease)

© Cafosa Gum S.A.U. – all rights reserved


Probiotic Gum (by Kracie Foods Ltd.)

The 2nd clinical study: gum improvements of periodontal disease patients

Change of RED COMPLEX count in saliva


P. gingivalis
week 0 4 significant difference

Placebo 8.57 ± 0.617 7.99 ± 0.450


Test 8.56 ± 0.285 8.03 ± 0.311 *

T. denticola
week 0 4 significant difference

Placebo 6.41 ± 0.550 6.15 ± 0.519


Test 6.80 ± 0.201 6.00 ± 0.481 *

T. forsythensis
week 0 4 significant difference

Placebo 7.27 ± 0.246 5.83 ± 0.681 *


Test 6.99 ± 0.274 5.28 ± 0.762 *

log mean±SE *:p<0.05


© Cafosa Gum S.A.U. – all rights reserved
Probiotic Gum (by Kracie Foods Ltd.)

Conclusions

9 Compressed Gum is a safe delivery


system for Probiotics

9 Clinical studies show the efficacy of


Probiotic Gum as an effective Oral
Care Agent

9 Chewing Gum inherent benefits


have synergistic action with
Probiotics, thus the format is even
more attractive

© Cafosa Gum S.A.U. – all rights reserved


Index

ƒ Medicated Chewing Gum available today

ƒ Compressed Gum: new insights for the future

ƒ Probiotic Gum

ƒ Energy Gum:
Developed in India by the National Institute of Pharmaceutical
Education & Research (NIPER)

Presented at the CRS (Controlled Release Society) 10th


International symposium (2010)

ƒ Cold Relief Gum

© Cafosa Gum S.A.U. – all rights reserved


Energy Gum (by NIPER)

Formula & Parameters

Compressed Medicated Gum Formula containing:


– Caffeine (100 mg)
– HiG PWD 01
– Flavours
– Intense Sweetener
– Lubricant

Parameters measured:
ƒ Uniformity of Mass: 0.3%<5.00% - acceptable
ƒ Uniformity of content of optimized formula: 99.21% (98.5-101.5%)
– passes as per EP
ƒ %weight loss in Friability test: 0.14% (<1.00%) – passes as per EP

© Cafosa Gum S.A.U. – all rights reserved


Energy Gum (by NIPER)

Caffeine Release Evaluation

[C] MCG Performance Evaluation for determination of % Drug Release by


“CHEW OUT” Study with 6 volunteers who chewed at different time intervals

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.

Actual drug content – Residual drug content =


Released drug content from MCG

© Cafosa Gum S.A.U. – all rights reserved


Energy Gum (by NIPER)

Energy gum

% caffeine release from MCG


in 15 minutes: 91.68%

B:
am
He ount
alth of
in G
um

© Cafosa Gum S.A.U. – all rights reserved


Energy Gum (by NIPER)

Conclusions

Directly compressible chewing gum with caffeine is effective in terms


of:

9 Viability of formulation

9 Fast onset of action due to the correct release of active ingredient

9 Attractive and pleasant delivery system

© Cafosa Gum S.A.U. – all rights reserved


Index

ƒ Medicated Chewing Gum available today

ƒ Compressed Gum: new insights for the future

ƒ Probiotic Gum

ƒ Energy Gum

ƒ Cold Relief Gum:


Developed in India by the National Institute of
Pharmaceutical Education & Research (NIPER)

© Cafosa Gum S.A.U. – all rights reserved


Cold Relief Gum (by NIPER)

Credits

Formulation development of Directly Compressible Taste Masked


Medicated Chewing Gum for Cold Relief

ƒ By Shivang Chaudhary
ƒ Department of Pharmaceutics
ƒ Niper, Ahmedabad

© Cafosa Gum S.A.U. – all rights reserved


© Copyrighted by Shivang Chaudhary- NIPER,Ahmedabad
Cold Relief Gum (by NIPER)

Study performed

Medicated Chewing Gum for Cold Relief using Cetirizine 2HCl

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

© Cafosa Gum S.A.U. – all rights reserved


© Copyrighted by Shivang Chaudhary- NIPER,Ahmedabad
Cold Relief Gum (by NIPER)

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%)

Active ingredient (CTZ‐βCD) Complex 98.5 mg (7.03%)


(1.00%)
Active ingredient +Plastisizer Menthol
14 mg
Softening agent Soy lecithin 21 mg (1.50%)

High intensity sweetener Aspartame (E 951) 42 mg (3.00%)

Natural Flavouring agent Peppermint flavour  0.5 mg (0.35%)

Anti-adherant Purified Talc 28 mg (2.00%)

Lubricant Magnesium stearate 14 mg (2.00%)

Glidant Colloidal silicon dioxide 5.6 mg (0.40%)

Opacifier Titanium dioxide (E 171) 14 mg (1.00%)


Total 1400 mg 100%

© Cafosa Gum S.A.U. – all rights reserved


© Copyrighted by Shivang Chaudhary- NIPER,Ahmedabad
Cold Relief Gum (by NIPER)

Official product quality test

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

© Cafosa Gum S.A.U. – all rights reserved


© Copyrighted by Shivang Chaudhary- NIPER,Ahmedabad
Cold Relief Gum (by NIPER)

Product performance test - for drug release by “Chew Out” study

Each person chewed one chewing gum


sample for different time

The residual gums have been stretched up


to maximum, cut into small pieces

Small pieces dispersed in water: methanol


(70:30 v/v) mixture & sonicated for 1 hr
with heating & filtered

Analysed by UV spectrophotometer at
230.4 nm to determine residual drug
content in MCG

© Cafosa Gum S.A.U. – all rights reserved


© Copyrighted by Shivang Chaudhary- NIPER,Ahmedabad
Cold Relief Gum (by NIPER)

Unequal hexagonal symmetry = interindividual variability in % drug release


Release % A

Release after:
F B
1 minute

2 minutes

5 minutes

10 minutes

15 minutes
E C

© Cafosa Gum S.A.U. – all rights reserved


D
Cold Relief Gum (by NIPER)

Cetirizine Release Profile

f
ount o
m
B: a in Gum
lth
Hea

© Cafosa Gum S.A.U. – all rights reserved


© Copyrighted by Shivang Chaudhary- NIPER,Ahmedabad
Cold Relief Gum (by NIPER)

Conclusion

9 The study demonstrates the efficacy of compressed gum as a high potential


drug delivery system in new applications as Cough&Cold / Allergy products

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

9 Released average 90.28% of CTZ (n=6) within 15 minutes of chewing


(which is half of the normal average chewing time) in chew out study

9 Interindividual variability in % CTZ-release was remained only up to 1-3


minutes, afterwards very less inter-individual variability was observed in
%CTZ release

© Cafosa Gum S.A.U. – all rights reserved


© Copyrighted by Shivang Chaudhary- NIPER,Ahmedabad
Cold Relief Gum (by NIPER)

Presentation Publication

© Cafosa Gum S.A.U. – all rights reserved


© Copyrighted by Shivang Chaudhary- NIPER,Ahmedabad
Questions?

Thank you

© Cafosa Gum S.A.U. – all rights reserved

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