S.No |
Therapeutic Category/Sub Category |
Reference Listed Drug |
Product Name |
Technology |
Dosage Form |
Status Development, Dissolution Data |
Scale-up |
BE Study |
Comments |
S.No |
Therapeutic Category/Sub Category |
Reference Listed Drug |
Product Name |
Technology |
Dosage Form |
Status Development, Dissolution Data |
Scale-up |
BE Study |
Comments |
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1 |
Pain management / Narcotic analgesic |
Actiq/ Teva |
Fentanyl Citrate Oral Transmucosal Lozenge (200 ug /400 ug /600 ug /800 ug /1200 ug /1600 ug lolli-pop). |
ZSEATRIXX-LP. Low dose drug 200 to 1600 mcg in large 2.0 gram tablet. Met content uniformity testing |
Transmucosal Lozenge |
Complete. Lolli-pop with insertion developed. QC in vitro results matched perfect |
complete except, Stick insertion machine - holding |
complete. Study done with 12 USA subjects. Results match with Control Actiq. |
Low dose drug 200 to 1600 mcg in large 2.0 gram tablet. Met content uniformity testing |
2 |
Pain management/NSAID |
Ultram ER/ Valeant |
Tramadol 300mg ER tablets.100 and 200 mg - dose proportionate |
ZSMARTCOAT: Multipolymers systems- soluble and insoulble, in aqueous and solvents. |
Extended release tablet |
Complete. QC in_vitro resuts matches perefect. F1 and F2 results are with in limits |
v |
TBD |
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GI- |
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1 |
GI tract/ Anti inflammatory |
Pentasa/ Shire US Manufacturing Inc |
Mesalamine 500mg coated beads CR capsules. |
ZSOL BEADS ZSMARTCOAT |
Extended release Beads in Capsule |
Complete. In-vitro results match with Control pentasa in all pH's. |
complete. In-Vitro results matchesin all pH's well |
Ready for testing.. Teva has stopped due to acquisition of Barr pharma. |
Good technology of Beads, drug layering, and coating.. |
2 |
GI tract/ Anti inflammatory |
Asacol HD/ Allergan |
Mesalamine 800mg Target control.delayed release tablets. |
ZSMARTCOAT |
Extended release tablet |
Development complete. In-vitro dissolution mateches well. Both F1 ND F2 ARE WITHIN LIMITS |
TBD |
Pilot study with 35 people was done. Did not match. Need further development |
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Weight Management |
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1 |
Weight Mangment |
Megace Nano beads suspension to Rapdimelt |
Megestrol Acetate |
Rapdmdelt |
|
Feassibility complete with |
|
Ready for complete development |
Ip Pending |
Psychotropic |
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1 |
Pysychotropic - anti depressant |
Effexor xl 24 hrs / Pfizer / beads - capsule |
Venlafaxine hcl capsule |
Minitabs, / ZSMART coat in Capsule |
Capsule with minitabs |
Development complete. In-Vitro dissolution - F1 and F2 is good match |
TBD |
Pilot bio with 12 subjects complete. Good match |
ExcellentMini-tablet delivery technology to replace beads |
2 |
Psychotropic - anti depressant |
Projac weekly Delayed release / Lilly / ??? |
Fluoxitine 90 mg Delayed release beads / capsule |
Minitablets / Zsmart coat, in a capsule |
Capsule with minitablets |
Development complete. In-Vitro dissolution matches well in all pH's. F1 and F2 is good |
TBD |
TBD |
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UTI |
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1 |
BPH -UTI Over active bladder |
Detrol LA beads capsule / Pfizer |
Tolteridine 4mg capsule |
Kortabs - minitabs, / ZSMART coat / capsule |
minitabs in a capsule |
Development complete. Dissolution Matches in all pH's. F2 and F1 are good |
TBD |
TBD |
Excellent technology - minitablets. Better than Beads |
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Cardio |
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1 |
Cardiovascular system/ Antihypertensive (β blocker) |
Toprol XL/ Astrazeneca |
Metoprolol Succinate 200mg, 100 mg and 50 mg, 25 mg ER tablets. |
Beads,Zsamrt coat - CCTabs- cushion TABLETS, Coating |
Extended release tablet |
Development complete for 1)200 mg and 2) 50 mg. Matches in all pH's. F1 and Fe factorsa re in limits |
Pilot scale complete |
Pilot bio results mixed. Matches well in Fasting, slightly higer in Food testing. |
Excellent beads - caoting - Cushioning tablets technology applicable to other products |
2 |
Cardiovascular system/ Antihypertensive (Calcium channel blocker) |
Tiazec beads capsule |
Diltiazem Hcl 420 mgbeads capsule |
Korbeads / ZSMART Coat / capsule |
Extended release beads in capsule |
Development complete. Dissolution Matches in all pH's. F2 and F1 are good |
Pivotal scale up complete |
Teva's full study came well except need slight less coating to increse the release |
Good mfg of drug beads and Caoting in mfg scale |
2 |
Cardiovascular system/ Antihypertensive (Calcium channel blocker) |
Cardizem® LA/ Abbott Laboratories |
Diltiazem HCl 420mg ER Tablets. |
Beads - coating - CC (cushioning) tablets |
Extended release tablet |
Deveopment complete. Cushioning Compressed tabs tech with beads and coating. |
TBD |
TBD |
Excellent beads - coating - cushion compressed tablets technology. |
3 |
Cardiovascular system/ Anti hyper lipidemic |
Niaspan/ Abbott laboratories |
Niacin 1000mg/750mg/500mg extended release tablets. |
Matrix and ZSMARTCOAT |
Extended release tablet |
Complete. In-Vitro dissolution with good F2 and F1 factors in all pH's |
TBD |
TBD |
Large dose delivery technology. |
4 |
Cardiovascular system/ Anti hyper lipidemic |
Advicor /A Abbott laboratories |
Niacin 1000mg extended release and Lovastatin 20mg immediate release tablets |
Matrix and coating. Dual drugs |
Extended release tablet |
Development complete. With good in-vitro dissolution results in all pH'sTBD |
|
TBD |
Large dose delivery technology. With second drug in coating |
6 |
Cardio - Hypertension |
Inderol LA / beads in capsules / 24hrs release / ANI Pharmaceuticals |
Propanolol hcl LA / Capsule |
Beads - coating -capsule |
beads in capsule |
Development complete. In-vitro dissolution matches in all pH's. Good F2 and F1 results |
Scaled up fro Pivotals tudy |
Good results. Teva did the study |
good beads - drug coating and coating for control release |
7 |
Cardio - Hyertension |
Adalat cc 90 mg, 60 , 30 mg tablets / procardia xl - pfizer |
Nifedipine 90 mg xl layered tablet |
Tablet inside tablet and matrix - coating |
Tablet |
Development complete. In-Vitro dissoltion - F1 and F2 is good match |
Scaled up for Pilot biostudy |
Pilot biostudy complete. Results in fasting is good. Food effect resultsa re slightly off. |
Uniqute tech paltform. Matrix release - tablet inside tablet and coating |
8 |
mrd - beads - capsules / combo drug stability |
1.400-002 Dipyridamol Modified Release; beads - Capsules 200mg / |
antiplatelet agent intended for oral administration. |
Beads - coating / capsule |
Capsule |
Development complete. Dissolution Matches in all pH's. F2 and F1 are good |
TBD |
TBD |
TBD |
CNS |
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9 |
Anti-epileptic |
Leviteracetam 500mg, 750 mg Extended release tablets 500mg & 750mg |
400-004: Tabs - MRD / CNS |
matrix tabs |
Keppra XR / boeringer |
development complete. In-vitro dissolution is good |
TBD |
TBD |
TBD |
Diabetic |
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1 |
Metabolic/ Anti diabetic |
Glumetza /Depmed |
Metformin HCl 1000mg ER tablets. |
FLOATING / ZSMARTCOAT |
Extended release tablet |
Development complete. Unique Floating tabs in Stomach over extended time. Matches dissolution and timings in all pH's. |
TBD |
TBD |
Excellent floating tablets technology . Releases at Stomach pH over extended time. |
2 |
Ant diabetic & Lipid lowering |
tabs - combo -mrd tabs; 400-001 |
Metformin Hydrochloride extended release and Rosuvastatin bilayer tablets 500mg/10mg & 750mg/20mg |
Matrix and coating with second drug |
Extended released coated tablet |
Devlopment complete. Matched all pH's. good F2 and F1 results |
TBD |
TBD |
there is no Reference dual drug product in USA |
COUGH |
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1 |
Antitussive |
Delsym, Reckitt Benckiser |
Dextromethorphan HBr 12hr Extended release RAPIDMELT Cough Suppressant – Orange Flavor |
LIQUID CR - SUSPENSION |
Rapdimelt- |
Development complete. Matches relase profiles. |
TBD |
TBD |
TBD |
SMOKE - Cessation |
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1 |
|
Nicorette and other chewing gums / many companies |
Nicotine resin complex gums |
Medicated gum release with Park and Chew with different flavors |
Chewing gum pallet |
Development complete. Amtches release profile |
Scaled for pilot biostudy |
TBD |
TBD |
2 |
|
New Nicotine relase |
Nicotine tartrate-2 and 4 mg |
Instant release and long lasting release….for quick relief of craving |
Chewing gum pellet |
New technology for fast release in five minutes. Excellent release profile for fast craving release. New Chewing gum base release |
Scaled up gum base and Chewing gums |
Good pilot bioresults with more than 25% release in first 5 minutes and more at alater stages. No Park and chew |
Excellent Gum, medicated gums and Chewing gum Base paltform for many more products. |
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