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Proton pump inhibitors- ome, esome, lanso, pant

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  • Nice Video,Thanks for sharing.Enaldrugs is an Betahistine Dihydrochloride Manufacturer In India.
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Proton pump inhibitors- ome, esome, lanso, pant

  1. 1.  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
  2. 2.  Proton pump Inhibitors at Murli Krishna Pharma…….  1. Omeprazole Pellets  2. Esomeprazole Pellets  3. Lansoprazole Pellets  4. Pantoprazole Pellets
  3. 3. 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%
  4. 4. 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.
  5. 5. OMEPRAZOLE 6. Bioequivalence Data:
  6. 6. 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 ± SD 0.14 ± 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
  7. 7. 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
  8. 8. 1. Description:  Proton Pump Inhibitor (PPI).  Used for the treatment of acidity, GERD and ulcers 2. Patent Holders:  Takeda GMBH 3. Our Non-Infringement:  Use of excipient and process 4. 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
  9. 9. 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.
  10. 10. LANSOPRAZOLE 6. Bioequivalence Data:
  11. 11. LANSOPRAZOLE Parameter Lansoprazole Agopton MKPPL Cmax (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 ± SD 0.66 ± 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
  12. 12. 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.
  13. 13. 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
  14. 14. 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 - 80 Tween – 80 Purified water Purified water
  15. 15. Product/Statistics Cmax (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)
  16. 16. 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 3130.89 SD 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
  17. 17. 0 20 40 60 80 100 120 0 10 20 30 40 50 60 70 %DrugRelease Time in (min) Dissolution (%) Nexium Dissolution (%) MKPPL 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)
  18. 18. 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.
  19. 19. 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 USFDA Registered 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.
  20. 20. PANTOPRAZOLE 1. 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
  21. 21. 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.
  22. 22. 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
  23. 23. 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
  24. 24. DOCUMENTS AVAILABLE DOCUMENTATIONS: DMF: EDMF in CTD format is available. STABILITY DATA: Both accelerated & Long Term stability is available.
  25. 25.  MKPPL product was Exported to:  Mexico  Columbia  Turkey  Iran  Egypt  Cyprus  Bangladesh
  26. 26.  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. Shirur Dist. Pune 412209, Maharashtra, INDIA Tel: +91 2138 675613 / 600 Web: www.mkppl.com  E-mail id: sudha@mkppl.com  Mobile: +91 9225507296

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