Download - Medicated Chewing Gum- Success Stories- Shivang Chaudhary

Success Stories

SchwarzenbekNovember 15th – 16th

Marc RibéProject Mgr Pharma BusinessCAFOSA

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

Index

Medicated Chewing Gum available today

Compressed Gum: new insights for the future

Probiotic Gum

Energy Gum

Cold Relief Gum


NRT Gum (Nicotine): – Nicorette®, Nicotinell®, Niquitin®

Motion Sickness Gum (Meclozine, Dimenhydrinate):– Travvel®, Dramine®, Biodramina®

Oral Care Gum (Chlorhexidine, Probiotics):– Hexit®, ProbioticGum™

Digestive Gum (Sodium Picosulphate):– Kritel Chicles®

Energy Gum (Caffeine):– StayAlert®, Gum Alert

Products commercially available

MCG available today


Compressed Gum

The compressed gum production allows pharmaceutical companies toadopt chewing gum as an innovative drug delivery system

Patient compliance

Fast onset of action of the drug

New Pharmaceutical Developments

Line Extensions of existing products

Specific Age Categories: Teenagers, Children

New Insights for the future


Index



Probiotic Gum: Developed in Japan by Kracie Foods Ltd.

Energy Gum

Cold Relief Gum


Probiotic Gum (by Kracie Foods Ltd.)

Compressed Gum: Formulation with HiG with Lactic Acid Bacteria (LAB)

Survival results of Probiotic tested: optimised due to low water activity

1.0E+04

1.0E+05

1.0E+06

1.0E+07

1.0E+08

1.0E+09

1.0E+10

0 1 2 3 4

Treatment time (week)

LA

B (

CFU

/g) Compressed gum (HiG)

Stick gum



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 weeks2nd 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

(1st examination) (2nd examination)

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

Basic examination


cells

/ml

1.0E+06

1.0E+07

1.0E+08

Total bacteria count in saliva

weeks


Showed significant decrease of total bacteria count in saliva by ingesting LAB contained HiG for 4 weeks


Decrease

◆Placebo

■Test

：P＜0.05＊



Showed significant decrease of Porphyromonas gingivalis count in saliva by ingesting LAB contained HiG for 4 weeks


Decrease

cells

/ml

Total P.g. count in saliva

weeks

◆Placebo

■Test

：P＜0.05＊

1.0E+01

1.0E+02

1.0E+03

1.0E+04

1.0E+05

※P.g：, major periodontal pathogen



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



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 resultsShowed 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)



Change of RED COMPLEX count in saliva

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

P. gingivalisweek 0 4 significant difference

Placebo 8.57 ± 0.617 7.99 ± 0.450Test 8.56 ± 0.285 8.03 ± 0.311 *

T. denticolaweek 0 4 significant difference

Placebo 6.41 ± 0.550 6.15 ± 0.519Test 6.80 ± 0.201 6.00 ± 0.481 *

T. forsythensisweek 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



Conclusions

Compressed Gum is a safe delivery system for Probiotics

Clinical studies show the efficacy of Probiotic Gum as an effective Oral Care Agent

Chewing Gum inherent benefits have synergistic action with Probiotics, thus the format is even more attractive




Probiotic Gum

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)

Cold Relief Gum

Index


Energy Gum (by NIPER)

Formula & Parameters

Compressed Medicated Gum Formula containing:– Caffeine (100 mg)– HiG PWD 01– Flavours– Intense Sweetener– Lubricant

Parameters measured:Uniformity of Mass: 0.3%<5.00% - acceptableUniformity 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



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



Energy gum

% caffeine release from MCG in 15 minutes: 91.68%

B: amount of Health in Gum



Conclusions

Directly compressible chewing gum with caffeine is effective in terms of:

Viability of formulation

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

Attractive and pleasant delivery system




Probiotic Gum

Energy Gum

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

Index


Cold Relief Gum (by NIPER)

Credits

Formulation development of Directly Compressible Taste Masked Medicated Chewing Gum for Cold Relief

By Shivang ChaudharyDepartment of PharmaceuticsNiper, Ahmedabad

© Copyrighted by Shivang Chaudhary- NIPER,Ahmedabad



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




Complete Formula

Optimized Formula of CTZ-MCG by Direct compression method

Category Drug or Excipients in mg. in %

Gum powder Health In Gum 1162.4mg (83.00%)

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

Active ingredient +Plastisizer Menthol14mg

(1.00%)

Softening agent Soy lecithin 21mg (1.50%)

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

Natural Flavouring agent Peppermint flavour 0.5mg (0.35%)

Anti-adherant Purified Talc 28mg (2.00%)

Lubricant Magnesium stearate 14mg (2.00%)

Glidant Colloidal silicon dioxide 5.6mg (0.40%)

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

Total 1400 mg 100%




Official product quality test

Results Of Official Product Quality Assessment Tests

Sr No. Official Tests Observations Compliance criteria Result

01 Uniformity of MassOut of 20 MCG; none deviated from ±5%

NMT 2 deviate from ±5% Pass

02 Uniformity of Contentall 10 MCG contain CTZ within limits

95% < x < 105% Pass

03 Friability testingtotal weight loss = 0.07% of 10 MCG

Weight loss< 1.00% Pass




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



F

E

B

C

D

AUnequal hexagonal symmetry = interindividual variability in % drug release


Release after:

1 minute

2 minutes

5 minutes

10 minutes

15 minutes

Release %



Cetirizine Release Profile


B: amount of

Health in Gum



Conclusion

The study demonstrates the efficacy of compressed gum as a high potential drug delivery system in new applications as Cough&Cold / Allergy products

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

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

Interindividual variability in % CTZ-release was remained only up to 1-3 minutes, afterwards very less inter-individual variability was observed in %CTZ release




Presentation Publication



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Download - Medicated Chewing Gum- Success Stories- Shivang Chaudhary

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