ORAL THIN FILMS

ORAL THIN FILMS

The new drug delivery system set to revolutionise the pharma industry.

THINORAL TECHNOLOGY

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

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

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

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

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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.

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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.

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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 BUSINESS GROWTH

evolution of OTF

Several OTF products have already been out-licensed to major pharmaceutical companies. More are under discussion with key pharma players and also under own registration in several markets.

ZIM has developed 19 products and commercialized 13 of them within 3 years Technology developed is indigenous consisting of equipment design (manufacturing and testing) as well as formulation development resulting in a manufacturing system capable of high throughput commercial output of high quality oral films.

OTF DISPERSION FORMS

Conversion of IM/SC injectable dosage forms into Sublingual Formulations

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

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
sublingual

Multilayer Films for Fixed Dose Combinations

  • Suitable for Incompatible actives
  • Actives with different release profiles can be formulated in one film
  • Proprietary technology
  • Can also be used for trans-mucosal films that require inert backing membranes
  • Can be filed as an ANDA application
conversion

Oral Care Products

  • Orodispersible films with anti-infective and antibacterial properties are already developed
  • Mucoadhesive film technology platform is used for developing other oral care products
  • Probiotic films under development for regeneration of microbial natural flora to be used as Supplement Therapy in dental care
sublingual

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

  • RAMP UP IN THE BUSINESS
  • Consistent increase in Product Permissions and Registrations
otf-chart
otf-chart

OTF PRODUCTS

PRODUCT NAME STRENGTH (mg) THERAPEUTIC USE PACK PRESENTATION

Ondansetron (Hydrochloride)

4 / 8

Anti-Emetic

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

Methylcobalamin

1500 mcg

Vitamin B12 Supplement

10 X 1 AAP

Montelukast (Sodium)

10

Anti-Asthmatic / Anti-Allergic

10 X 1 AAP

Vitamin D3

2000 IU

Vitamin D3 Supplement

10 X 1 AAP

Menthol Mouth Freshener

...

Mouth Freshener (Mint Flavour) & Others

30 strips
/films per cassette

Abbrevation: AAP = Alu-Alu Pouch

PRODUCT NAME STRENGTH (mg) THERAPEUTIC USE PACK PRESENTATION

ONDANSETRON (Hydrochloride)

2

Anti-Emetic

10 X 1 AAP

Tadalafil

2.5

Benign Prostatic Hyperplasia, Erectile Dysfunction

10 X 1 AAP

Melatonin

0.5 / 1 / 3 / 5

Sedatives & Hypnotics

10 X 1 AAP

Folic Acid

0.5

Vitamins & Minerals

10 X 1 AAP

Simethicone

62.5

Anti- Flatulent

10 X 1 AAP

Levocetirizine Dihydrochloride

2.5

Anti-Allergic / Nasal Decongestant

10 X 1 AAP

Montelukast (Sodium)

4 / 5

Anti-Asthmatic/ Anti-Allergic

10 X 1 AAP

Rizatriptan Benzoate

5/ 10

Anti-Migraine

10 X 1 AAP

Voglibose

0.2/ 0.3

Anti-Diabetic

10 X 1 AAP

Zolmitriptan

2.5 / 5

Anti-Migraine

10 X 1 AAP

Nicotin (Resinate)

2/4

Cholinergic Drugs

10 X 1 AAP

Abbrevation: AAP = Alu-Alu Pouch

ZIM'S SELECTED OTF PIPELINE
PHARMACEUTICAL PRODUCTS IN DEVELOPEMENT STAGE

PRODUCT CODE Theraputic Indication Formulation Developement Pilot Study Pivotal Study Regulatory Submission Market Launch

1

A00116

Vitamin D Deficiency

2

B00079

Erectile Dysfunction

3

B00029

Antiallergic

4

B00027

Diabetic Neuropathy

5

B00026

Erectile Dysfunction, Bengin Prostatic Hyperlisia

6

B00026

Antiashtmatic

7

B00043

Antidiabetic

8

A00197

Anti Alzehmeric

9

A00747

Migraine

10

A00121

Migraine

Abbrevation: AAP = Alu-Alu Pouch