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Generic Drug;International & National Challenges

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Dr.Faheem Lakhani

The document summarizes international and national challenges pertaining to generic drugs. For international challenges, it provides examples of generic drug recalls due to containing undeclared active ingredients, incorrect drug strengths leading to overdoses, and dissolution failures reducing drug effectiveness. For national challenges, it analyzes examples of non-approved drug formulations and dosage forms in Pakistan that could impact bioavailability, stability, and safety. The conclusion emphasizes the importance of only approving generic drugs with formulations and strengths supported by evidence from reference drug regulatory agencies.

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Pharmaceutical Manufacturing Generic Drug; International & National Challenges Faheem Lakhani Plant Manager, Platinum Pharmaceuticals.
Flow of Presentation Concept of Generic Drug Challenges pertaining to Generic Drugs International National Take Home Massage
Generic Drug A pharmaceutical drug, equivalent to a brand name product in: Dosage Strength Route of administration Quality Performance And intended use Must contain the same active ingredient as the original brand name formulation.
International Challenges Pertaining to Generic Drug International Cases
Case#1: Digoxin tab Manufactured in New jersey by the Actavis group Product recalled due to strength of tabgreater than labeled a potentially lethal overdose, caused heart failure. Dose of Digoxin has to be just right
Case#2: Caverflo natural herbal Coffee Presence of undeclared active ingredients (Sildanafil, Tadelafil & undeclared milk). Ingredient may interact with nitrates in some prescription drug, such as nitroglycerin , and may lower blood pressure to dangerous levels. People having allergy or severe sensitivity to milk.
Case#3: Paliperidone extended release Tab Teva Pharmafor the treatment of Schizophrenia Dissolution failure could reduce effectiveness in treating a patients mental and /or mood symptoms, including suicidal thought and behavior, mental hospitalizations, aggressive behavior.
Case#4: Piyanping Anti-Itch Lotion The product was manufactured using the active pharmaceutical ingredient dexamethasone rather than hydrocortisone. Effecting Adrenal suppression,( high blood sugar , weakened immunity, electrolyte imbalances, slowing of growth in children)
Case#5: Venlafaxine Anti depressant drug 3 lots of venlafaxine XR were recalled due to all three lots were run on the same packaging line. Approx. 160,000 bottle were recalled Tikosyn ( a medicine use to treat heart arrhythmias) was found in an Venlafaxine XR bottle.
National Challenges Pertaining to Generic Drug Sorry ! We Dont have any Recalls
Case#1: Co-Plavix; Antiplatelet Drug Innovator drug available worldwide as Clopidogrel with Aspirin as immediate release film coated tablet with bilayer tablet. Taking enough medicine to prevent clotsimportant. Pakistani product. available in tablet in tablet with Aspirin as Enteric coat and Clopidogrel as immediate release. Bilayer Tablet in Tablet
Case#2: Montelukast Sodium 10mg Chewables Only 10mg film coated tablets as approved by ref agencies. May impact: 1. Bioavailability 2. Drug dissolution Profile 3. Clinical and Safety studies
Case#3: Montelukast sodium 5mg/5ml DP The innovators instructions for administrations are as follows: The packet should not be opened until ready to use. After opening the packet, the full dose (with or without mixing with baby formula, breast milk, or food ) must be administered within 15 minutes. If mixed , SINGULAIR oral granules must not be stored for future use. Discard any unused portion. SINGULAIR oral granules are not intended to be dissolved in any liquid other than baby formula or breast milk for administration.
Case#4: Isotretinoin 20mg Hard Gelatin Cap. Isotretinoin degrades when exposed to light or atmospheric oxygen. Batches of drug substance are stored under argon and protected from light. Therefore, a powder filled hard gelatin capsule or tablet dosage form may not be stable.
Case#5: Levofloxacin 125MG/5ML DPS Drug is available only in USFDA in the form of Oral Solution, 25 mg/mL. Multi-use self-preserving aqueous solution of levofloxacin with pH ranging from 5.0 to 6.0. The appearance of Levofloxacin Oral Solution may range from clear yellow to clear greenish-yellow. This does not adversely affect product potency. (Ref: US FDA)
Case#6: Rabeprazole 20 Mg CAP. Rabeprazole (as 20mg..Sodium enteric coated pellets) Not available in reference drug regulatory agencies. Tablet dosage forms are available. May impact: 1. Bioavailability 2. Drug dissolution Profile 3. Clinical and Safety studies
Case#7: Orlistat 60MG CAPS. Xenical is presented as a conventional hard gelatin capsule (size 1) containing pellets with an active substance concentration of 50%.
Case#8: Famotidine 40 MG/5ML Sus. Not approved by reference drug regulatory agencies. Internationally available formulation is dry powder for suspension in the strength of 40 mg/ 5 ml.
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Generic Drug;International & National Challenges

  • 1. Pharmaceutical Manufacturing Generic Drug; International & National Challenges Faheem Lakhani Plant Manager, Platinum Pharmaceuticals.
  • 2. Flow of Presentation Concept of Generic Drug Challenges pertaining to Generic Drugs International National Take Home Massage
  • 3. Generic Drug A pharmaceutical drug, equivalent to a brand name product in: Dosage Strength Route of administration Quality Performance And intended use Must contain the same active ingredient as the original brand name formulation.
  • 4. International Challenges Pertaining to Generic Drug International Cases
  • 5. Case#1: Digoxin tab Manufactured in New jersey by the Actavis group Product recalled due to strength of tabgreater than labeled a potentially lethal overdose, caused heart failure. Dose of Digoxin has to be just right
  • 6. Case#2: Caverflo natural herbal Coffee Presence of undeclared active ingredients (Sildanafil, Tadelafil & undeclared milk). Ingredient may interact with nitrates in some prescription drug, such as nitroglycerin , and may lower blood pressure to dangerous levels. People having allergy or severe sensitivity to milk.
  • 7. Case#3: Paliperidone extended release Tab Teva Pharmafor the treatment of Schizophrenia Dissolution failure could reduce effectiveness in treating a patients mental and /or mood symptoms, including suicidal thought and behavior, mental hospitalizations, aggressive behavior.
  • 8. Case#4: Piyanping Anti-Itch Lotion The product was manufactured using the active pharmaceutical ingredient dexamethasone rather than hydrocortisone. Effecting Adrenal suppression,( high blood sugar , weakened immunity, electrolyte imbalances, slowing of growth in children)
  • 9. Case#5: Venlafaxine Anti depressant drug 3 lots of venlafaxine XR were recalled due to all three lots were run on the same packaging line. Approx. 160,000 bottle were recalled Tikosyn ( a medicine use to treat heart arrhythmias) was found in an Venlafaxine XR bottle.
  • 10. National Challenges Pertaining to Generic Drug Sorry ! We Dont have any Recalls
  • 11. Case#1: Co-Plavix; Antiplatelet Drug Innovator drug available worldwide as Clopidogrel with Aspirin as immediate release film coated tablet with bilayer tablet. Taking enough medicine to prevent clotsimportant. Pakistani product. available in tablet in tablet with Aspirin as Enteric coat and Clopidogrel as immediate release. Bilayer Tablet in Tablet
  • 12. Case#2: Montelukast Sodium 10mg Chewables Only 10mg film coated tablets as approved by ref agencies. May impact: 1. Bioavailability 2. Drug dissolution Profile 3. Clinical and Safety studies
  • 13. Case#3: Montelukast sodium 5mg/5ml DP The innovators instructions for administrations are as follows: The packet should not be opened until ready to use. After opening the packet, the full dose (with or without mixing with baby formula, breast milk, or food ) must be administered within 15 minutes. If mixed , SINGULAIR oral granules must not be stored for future use. Discard any unused portion. SINGULAIR oral granules are not intended to be dissolved in any liquid other than baby formula or breast milk for administration.
  • 14. Case#4: Isotretinoin 20mg Hard Gelatin Cap. Isotretinoin degrades when exposed to light or atmospheric oxygen. Batches of drug substance are stored under argon and protected from light. Therefore, a powder filled hard gelatin capsule or tablet dosage form may not be stable.
  • 15. Case#5: Levofloxacin 125MG/5ML DPS Drug is available only in USFDA in the form of Oral Solution, 25 mg/mL. Multi-use self-preserving aqueous solution of levofloxacin with pH ranging from 5.0 to 6.0. The appearance of Levofloxacin Oral Solution may range from clear yellow to clear greenish-yellow. This does not adversely affect product potency. (Ref: US FDA)
  • 16. Case#6: Rabeprazole 20 Mg CAP. Rabeprazole (as 20mg..Sodium enteric coated pellets) Not available in reference drug regulatory agencies. Tablet dosage forms are available. May impact: 1. Bioavailability 2. Drug dissolution Profile 3. Clinical and Safety studies
  • 17. Case#7: Orlistat 60MG CAPS. Xenical is presented as a conventional hard gelatin capsule (size 1) containing pellets with an active substance concentration of 50%.
  • 18. Case#8: Famotidine 40 MG/5ML Sus. Not approved by reference drug regulatory agencies. Internationally available formulation is dry powder for suspension in the strength of 40 mg/ 5 ml.

Editor's Notes

  • #8: Product that has failed dissolution could result in less drug being absorbed
  • #9: Case# 08/2017 Dexamethasone is a higher potency steroid than hydrocortisone
  • #10: Due to potentially fatal combination.
  • #12: preventbloodcells called platelets from clumping together to form a clot.