PROTONPUMP INHIBITORS
MURLI KRISHNA PHARMA
COMPANY PROFILE Murli Krishna Pharma is an EU-GMP/ WHO-GMP and PIC/S
approved plant. We manufacture pre finished formulation intermediates that can
be directly employed into formulating solid dosage forms, can be blended with suspension base for use in suspensions. We also have developed nano particles for direct use in ophthalmic solutions and injectables
We are one among the global top 10 NDDS manufacturers and one of the five regulatory compliant and regulatory approved manufacturers of pre finished formulation intermediates.
We provide a complete patient friendly solution to the generic manufacturers of the World.
MURLI KRISHNA PHARMA
PROTON PUMP INHIBITORS
Proton pump Inhibitors at Murli Krishna Pharma…….
1. Omeprazole Pellets 2. Esomeprazole Pellets 3. Lansoprazole Pellets 4. Pantoprazole Pellets
OMEPRAZOLE 1. Description:
Proton Pump Inhibitor (PPI). Used for the treatment of acidity, GERD and ulcers
2. Patent Holders:Astra Zeneca- Sweden
3. Our Non-Infringement:Use of excipients and process
4. Comparative Dissolution Data:
Time(Min)
Dissolution (%)Of ASTRAZENECA
(IG6638)
Dissolution (%)Of MKPPL
(B.No-ROMA-8001)
10 90.15% 87.76%
20 97.33% 96.47%
30 96.40% 95.80%
45 95.70% 96.10%
OMEPRAZOLE
5. Dissolution Profile:
Differential Factor (F1) was found to be 2.46 (0-15 is acceptable) Similarity Factor (F2) was found to be 73.48 (50-100 is acceptable)
Conclusion: From the above values of F1 and F2, it can be concluded that Omeprazole pellets manufactured at Murli Krishna Pharma compare favorably with that of the Innovator product.
OMEPRAZOLE
6. Bioequivalence Data:
OMEPRAZOLE
Report: Our product shows bioequivalent with innovator product
Parameter Omeprazole
AstraZeneca MKPPL
Cmax (ng/ml)Mean ± SD
625.63 ± 257.01 638.06 ± 216.27
AUC 0-24 (ng.h/ml)Mean ± SD
1906.86 ± 759.91 2010.21 ± 633.48
AUC 0-∞(ng.h/ml)Mean ± SD
1978.18 ± 746.12 2103.21 ± 621.79
Kel (h-1)
Mean ± SD0.14 ± 0.06 0.13 ± 0.05
t1/2 (h)Mean ± SD
5.78 ± 2.14 5.78 ± 1.74
Tmax (h)Median
2.5 2
OMEPRAZOLE
7. Variations of the Product:
Percentage: 7.5% to 30%
Mesh Size : 12#16, 12#14, 14#18, 16# 20, 18#20, 20#22, 22#24, 24#30, 30#40, 40#60
8. Documentation Available:EDMF, USDMF available.Stability Data: Both accelerated and long term stability is available.
9 Registrations:DMF logged in US & Europe, DMF Log in number: The product was registered in Colombia, Brazil, Turkey, Iran, Egypt, Switzerland, Mexico , Cyprus
1. Description: Proton Pump Inhibitor (PPI). Used for the treatment of acidity, GERD and ulcers2. Patent Holders: Takeda GMBH3. Our Non-Infringement: Use of excipient and process4. Comparative Dissolution Data:
Time(Min)
Dissolution (%)B.No:14140 Of AGOPTON
Dissolution (%)B.No. MKPPLR-LAN-09001B
Of MKPPL
0 0 0
10 47.2 35.5
20 100.1 99.4
30 100.2 100.9
40 100.5 98.6
50 98.5 97
60 96.6 94.6
LANSOPRAZOLE
LANSOPRAZOLE
5. Dissolution Profile:
Differential Factor (F1) was found to be 3.32 (0-15 is acceptable) Similarity Factor (F2) was found to be 64.81 (50-100 is
acceptable)
Conclusion: From the above values of F1 and F2, it can be concluded that Lansoprazole pellets manufactured at Murli Krishna Pharma compare favorably with that of the Innovator product.
LANSOPRAZOLE
6. Bioequivalence Data:
LANSOPRAZOLE
Parameter Lansoprazole
Agopton MKPPLCmax (ng/ml)Mean ± SD
781.20 ± 306.86 748.38 ± 268.65
AUC 0-t(ng.h/ml)Mean ± SD
1739.96 ± 1068.48 1726.36 ± 1045.38
AUC 0-∞(ng.h/ml)Mean ± SD
1812.69 ± 1096.86 1802.55± 1083.49
Kel (h-1)
Mean ± SD0.66 ± 0.21 0.65 ± 0.22
t1/2 (h)Mean ± SD
1.23 ± 0.63 1.21 ± 0.62
Tmax (h)Median
2 2
Report: Our product shows bioequivalent with innovator product
LANSOPRAZOLE
7. Variations of the Product:
Percentage: 7.5 % to 20 %Mesh Size: 12#16, 14#18, 16# 20, 18#20, 20#22, 22#24, 24#30, 30#40, 40#60
8. Documentation Available:USDMF & EDMF is available. Stability Data: Stability Data in Accelerated and Long Term is available.
9. Registrations & Exported: The product was exported to………………….. Columbia, Brazil, Turkey, Iran, Saudi Arabia, South Africa and some non-
regulatory markets.
ESOMEPRAZOLE
1. Description:Proton Pump Inhibitor (PPI). Used for the treatment of acidity, GERD and ulcer
2. Patent Holders:Astra Zeneca- Sweden
3. Our Non-Infringement:Use of excipients and process
4. Comparative Dissolution Data:Time(Min)
Dissolution (%)Of Nexium
(B.No- LB83S1)
Dissolution (%)Of MKPPL
(B.No-PDL/ESF-220709)
0 0 0
10 51.8 44.3
20 82.7 85.9
30 91.9 95.5
45 93.2 93.8
60 91.3 90.5
Nexium MKPPL
Sugar spheres Sugar spheres
Hypromellose Hypromellose
Hydroxypropyl cellulose Polyethylene Glycol - 6000
Glyceryl monostearate Sodium Lauryl Sulphate
Talc Talc
Magnesium Stearate Titanium Di-oxide
Methacrylic acid copolymer dispersion type C
Methacrylic acid copolymer dispersion
Triethyl citrate Tween - 80Tween – 80 Purified water
Purified water
Comparison of Ingredients
PK Parameters of Test and Reference (N=26): Fasting Study
Product/StatisticsCmax
(ng/mL)AUC0-t
(ng.h/mL)AUC0-∞
(ng.h/mL)
Ratio
T /R (%) 105.25 109.85 111.42
90% confidence interval (T Vs R)
Lower limit: 102.30 99.55 101.56
Upper limit: 119.84 121.20 122.23
Intra Subject CV (%) 25.52 20.96 19.71
Summary statistics of log transformed pharmacokinetic parameters (Esomeprazole Capsules 40mg)
PK Parameters of Test and reference (N=26): Fasting Study
Summary statistics of log transformed pharmacokinetic parameters (Esomeprazole Capsules 40mg)
Nexium Capsules (40mg) B.No.LB83S1
Cmax AUC0-t AUC0-∞
Mean 898.63 2762.10 2919.59
SD 386.22 2128.91 2280.44
CV% 42.98 77.08 78.11
Ratio of Geometric Mean (T/R) 105.25 109.85 111.42
Esomeprazole Capsules (40mg) B.No. PDL/ESF-220709
Cmax AUC0-t AUC0-∞
Mean 1006.47 2868.58 3130.89SD 326.75 1913.67 2254.04
CV% 32.46 66.71 71.99
Ratio of Geometric Mean (T/R) 105.25 109.85 111.42
Dissolution Profile: (900ml Phosphate buffer pH 6.8)
0 10 20 30 40 50 60 700
20
40
60
80
100
120
Dissolution (%) NexiumDissolution (%) MKPPL
Time in (min)
% D
rug
Rel
ease
Esomeprazole pellets 22.5% w/w Dissolution Conditions:Paddle, 100rpm, 900ml
Comparative Dissolution Profile:Differential factor (f1) was found to be 0.219 (0-15 is acceptable) Similarity factor (f2) was found to be 69.18 (50-100 is acceptable)
ESOMEPRAZOLE
5. Dissolution Profile:-
Differential Factor (F1) was found to be 2 (0-15 is acceptable) Similarity Factor (F2) was found to be 70 (50-100 is acceptable)
Conclusion: From the above values of F1 and F2, it can be concluded that Esomeprazole pellets manufactured at Murli Krishna Pharma compare favorably with that of the Innovator product.
ESOMEPRAZOLE
6. Variations of the Product:
Percentage: 7.5%, 8.5%, 10%, 22.0% & 22.5%
Mesh Size: 12#14, 12#16, 14#16, 14#18, 16#20, 18#22, 24#30
7. Documentation Available:DMF in CTD Format is available.
8. Registrations:USDMF Logged with the USFDARegistered in Bangladesh, Cyprus, Belgium, Mexico, Turkey, Algeria, Jordan, Saudi Arabia, Egypt etc.
9. Approvals : PIC/s and EU Approval available for site and Product till
2016 WHO GMP approval in place Global Approval from Pfizer, Sanofi, Sandoz and Merck.
PANTOPRAZOLE1. Description:
Proton Pump Inhibitor (PPI). Used for the treatment of acidity, GERD and ulcers
2. Patent Holders:Bayer-Germany
3. Our Non-Infringement:Use of excipients and process
4. Comparative Dissolution Data :
Time(Min)
Dissolution (%)Of
PDL-PAF-220709
Dissolution (%)B.No: 114181 Of BAYER
( PANTPAS )
0 0 0
10 68.8 72.1
20 94.3 96.1
30 100.5 101.2
45 100.6 100.5
60 98.4 99.1
PANTOPRAZOLE
5. Dissolution Profile:-
Differential Factor (F1) was found to be 1.36 (0-15 is acceptable) Similarity Factor (F2) was found to be 84.88 (50-100 is acceptable)
Conclusion: From the above values of F1 and F2, it can be concluded that Pantoprazole pellets manufactured at Murli Krishna Pharma compare favorably with that of the Innovator product.
PANTOPRAZOLE
6. Variations of the Product:
Percentage: 15%, 22.5%
Mesh Size: 12#14, 12#16, 14#16, 14#18, 16#20
7. Documentation Available:EDMF, USDMF available.Stability Data: Both accelerated and long term stability is available.
8 Registrations:DMF logged in US & Europe, DMF Log in number: The product was registered in Colombia, Brazil, Turkey, Iran, Egypt, Switzerland, Mexico , Cyprus
MKPPL
Product -Commercialized
Recently Developed Under-Development
Orlistat Pellets Aprepitant Pellets Mycophenolate Mofetil Pellets
Clarithromycin Pellets/Granules
Azithromycin Taste Masked Granules
Paclitaxel Nano Particles
Itraconazole Pellets Sirolimus Micro Pellets Brinzolamide Micro Pellets
Lansoprazole Pellets/Micro Pellets
Tacrolimus Pellets/Micro pellets
Duloxetine HCL EC Pellets
Esomeprazole Pellets Tamsulosin HCL SR Pellets
Voriconazole Micro Pellets
Pantoprazole Pellets Mesalamine Pellets Venlafaxine SR pellets
Omeprazole Pellets Everolimus Micro Pellets
PRODUCT PORTFOLIO
DOCUMENTS AVAILABLE
DOCUMENTATIONS:
DMF: EDMF in CTD format is available.
STABILITY DATA: Both accelerated & Long Term stability is available.
WORLDWIDE - SUPPLIES
MKPPL product was Exported to: Mexico Columbia Turkey Iran Egypt Cyprus Bangladesh
For further information please feel free to contact our Marketing team.
Address: Murli Krishna Pharma P. Ltd INDIA
D-98, M.I.D.C. Ranjangaon, Tal. ShirurDist. Pune 412209, Maharashtra, INDIATel: +91 2138 675613 / 600Web: www.mkppl.com
E-mail id: [email protected] Mobile: +91 9225507296
CONTACT US
