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

PAIN

 

 

 

 

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

 

GI-

 

 

 

 

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

 

 

 

 

Weight Management

 

 

 

 

 

 

1

Weight Mangment

Megace Nano beads suspension to Rapdimelt

Megestrol Acetate

Rapdmdelt

 

Feassibility complete with

 

Ready for complete development

Ip Pending

Psychotropic

 

 

 

 

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

 

UTI

 

 

 

 

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

 

 

 

Cardio

 

 

 

 

 

 

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

 

 

 

 

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

 

 

 

 

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

 

 

 

 

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

 

 

 

 

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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