Thinoral Technology

Oral Thin Films (OTF) is the latest addition to ZIM Labs stable.

It is one of the few companies globally and one of the very few companies in India to have mastered the OTF technology.

ZIM Labs Oral Thin Film (OTF) Technology is patented as Thinoral® with about 19 applied product/proccess patents for oral films globally.

It has received 24 DCGI product approvals & is awaiting 14 in India and 13 product approvals overseas.

Its rapidly dissolving, non-sticky films have a drug loading capacity as high as 100 mg of the active drug. The faster release profile alleviates solubility issues in poorly soluble drugs.

Unlike orally disintegrating tablets that are manufactured using lyophilisation or low compression pressure, the Thinoral® strips are flexible and offer ease of storage and transportation.

Thinoral® technology could also be used for delivery of drugs through sublingual and buccal absorption routes, showing improved bioavailability by avoiding first pass metabolism.

OTF
Dispersion Forms

Conversion of IM/SC injectable dosage forms into Sublingual Formulations

  • Non invasive mode of administration
  • Proprietary technology & non-infringing process
  • Will be filed as an NDA/ANDA application requiring clinical trails

Sublingual/
Buccal Films

  • Alternative for injectable
  • Improved bioavailability as first pass metabolism is avoided
  • Proprietary technology and non-infringing process
  • Can be filed as an ANDA application

ZIM Labs Products permissions and registrations

ZIM Labs has filed 37 patents, Registered over 170 formulations in various markets (mainly RoW).

OTF Products

Product Name Strength(mg) Theraputic Use Pack Presentation
Vitamin D3 2000 IU Vitamin D3 Supplement 10 X 1 AAP
Tadalafil 5 / 10 / 20 Benign Prostatic Hyperplasia, Erectile Dysfunction 10 X 1 AAP
Sildenafil (Citrate) 25 / 50 Erectile Dysfunction 10 X 1 AAP
Ondansetron (Hydrochloride) 4 / 8 Anti-Emetic 10 X 1 AAP
Montelukast (Sodium) 10 Anti-Asthmatic / Anti-Allergic 10 X 1 AAP
Methylcobalamin 1500 mcg Vitamin B12 Supplement 10 X 1 AAP
Menthol Mouth Freshener --- Mouth Freshener (Mint Flavour) & Others 30 strips /films per cassette
Product Name Strength(mg) Theraputic Use Pack Presentation
ONDANSETRON (Hydrochloride)2Anti-Emetic10 X 1 AAP
Tadalafil2.5Benign Prostatic Hyperplasia, Erectile Dysfunction10 X 1 AAP
Melatonin0.5 / 1 / 3 / 5Sedatives & Hypnotics10 X 1 AAP
Folic Acid0.5Vitamins & Minerals10 X 1 AAP
SimethiconeSimethiconeAnti- Flatulent10 X 1 AAP
Levocetirizine Dihydrochloride2.5Anti-Allergic / Nasal Decongestant10 X 1 AAP
Montelukast (Sodium)4 / 5Anti-Asthmatic/ Anti-Allergic10 X 1 AAP
Rizatriptan Benzoate5 / 10Anti-Migraine10 X 1 AAP
Voglibose0.2/ 0.3Anti-Diabetic10 X 1 AAP
Zolmitriptan2.5 / 5Anti-Migraine10 X 1 AAP
Nicotin (Resinate)2/4Cholinergic Drugs10 X 1 AAP

ZIM Labs Selected OTF Pipeline

Pharmaceutical products in developement stage

Product Code Thereputic Indication Formulation Developement Pilot Study Pivotal Study Regulatory Submission Market Launch
A00116Vitamin D Deficiency
A00747Migraine
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A00121Migraine
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B00026Erectile Dysfunction,
Bengin Prostatic Hyperlisia
B00079Erectile Dysfunction
B00027Diabetic Neuropathy
B00043Antidiabetic
--
B00026Antiasthmatic
B00029Antiallergic
A00197Anti Alzheimeric
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OTF Film