medicated chewing gum- success stories- shivang chaudhary
DESCRIPTION
Importance of the field: Over the years, patient convenience and patientcompliance-orientated research in the field of drug delivery has resultedin bringing out potential innovative drug delivery options. Out of which,medicated chewing gum (MCG) offers a highly convenient patient-compliantway of dosing medications, not only for special population groups withswallowing difficulties such as children and the elderly, but also for thegeneral population, including the young generation.Areas covered in this review: In this review, various formulation ingredients,different manufacturing processes, and assessment of in vivo and in vitrodrug release from MCG are thoroughly discussed along with the therapeuticpotential and limitations of MCG.What the reader will gain: Readers will gain knowledge about the rationaleand prominent formulation and performance evaluation strategies behindchewing gum as a drug delivery system.Take home message: The availability of directly compressible co-processedgum material enables rapid, safe and low-cost development of MCG as adrug delivery option. By MCG formulation, revitalization of old productsand reformulation of new patented products is possible, to differentiatethem from upcoming generics competition in the market.TRANSCRIPT
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
© Cafosa Gum S.A.U. – all rights reserved
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
© Cafosa Gum S.A.U. – all rights reserved
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
© Cafosa Gum S.A.U. – all rights reserved
Index
Medicated Chewing Gum available today
Compressed Gum: new insights for the future
Probiotic Gum: Developed in Japan by Kracie Foods Ltd.
Energy Gum
Cold Relief Gum
© Cafosa Gum S.A.U. – all rights reserved
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
© 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 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
© Cafosa Gum S.A.U. – all rights reserved
cells
/ml
1.0E+06
1.0E+07
1.0E+08
Total bacteria count in saliva
weeks
Probiotic Gum (by Kracie Foods Ltd.)
Showed significant decrease of total bacteria count in saliva by ingesting LAB contained HiG for 4 weeks
The 1st clinical study: improvements in saliva status and gum status
Decrease
◆Placebo
■Test
:P<0.05*
© Cafosa Gum S.A.U. – all rights reserved
Probiotic Gum (by Kracie Foods Ltd.)
Showed significant decrease of Porphyromonas gingivalis count in saliva by ingesting LAB contained HiG for 4 weeks
The 1st clinical study: improvements in saliva status and gum status
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
© 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 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)
© Cafosa Gum S.A.U. – all rights reserved
Probiotic Gum (by Kracie Foods Ltd.)
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
© Cafosa Gum S.A.U. – all rights reserved
Probiotic Gum (by Kracie Foods Ltd.)
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
© Cafosa Gum S.A.U. – all rights reserved
Medicated Chewing Gum available today
Compressed Gum: new insights for the future
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
© 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: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
© 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: amount of Health in Gum
© Cafosa Gum S.A.U. – all rights reserved
Energy Gum (by NIPER)
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
© Cafosa Gum S.A.U. – all rights reserved
Medicated Chewing Gum available today
Compressed Gum: new insights for the future
Probiotic Gum
Energy Gum
Cold Relief Gum:Developed in India by the National Institute of Pharmaceutical Education & Research (NIPER)
Index
© 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
By Shivang ChaudharyDepartment of PharmaceuticsNiper, Ahmedabad
© Copyrighted by Shivang Chaudhary- NIPER,Ahmedabad
© Cafosa Gum S.A.U. – all rights reserved
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
© Copyrighted by Shivang Chaudhary- NIPER,Ahmedabad
© Cafosa Gum S.A.U. – all rights reserved
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 1162.4mg (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%
© Copyrighted by Shivang Chaudhary- NIPER,Ahmedabad
© Cafosa Gum S.A.U. – all rights reserved
Cold Relief Gum (by NIPER)
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
© Copyrighted by Shivang Chaudhary- NIPER,Ahmedabad
© Cafosa Gum S.A.U. – all rights reserved
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
© Copyrighted by Shivang Chaudhary- NIPER,Ahmedabad
© Cafosa Gum S.A.U. – all rights reserved
F
E
B
C
D
AUnequal hexagonal symmetry = interindividual variability in % drug release
Cold Relief Gum (by NIPER)
Release after:
1 minute
2 minutes
5 minutes
10 minutes
15 minutes
Release %
© Cafosa Gum S.A.U. – all rights reserved
Cold Relief Gum (by NIPER)
Cetirizine Release Profile
© Copyrighted by Shivang Chaudhary- NIPER,Ahmedabad
B: amount of
Health in Gum
© Cafosa Gum S.A.U. – all rights reserved
Cold Relief Gum (by NIPER)
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
© Copyrighted by Shivang Chaudhary- NIPER,Ahmedabad
© Cafosa Gum S.A.U. – all rights reserved
Cold Relief Gum (by NIPER)
Presentation Publication
© Copyrighted by Shivang Chaudhary- NIPER,Ahmedabad
© Cafosa Gum S.A.U. – all rights reserved
Questions?
Thank you