Delivery Platform
Therapy Agnostic Products

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 OTF technology.

ZIM Labs Oral Thin Film (OTF) Technology is patented as Thinoral® with about 19 applied product/process 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 lyophilization or low compression pressure, the Thinoral® strips are flexible and offer ease of storage and transportation.

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

Dry/Wet granulation and direct compression are the two methods for the preparation of tablets.

The prime advantage of direct compression over wet granulation is cost since the latter requires fewer unit operations. This means less equipment, lower power consumption, less space, time and labor leading to the reduced production cost of tablets.

Direct compression is more suitable for moisture and heat sensitive APIs since it eliminates wetting and drying steps and increases the stability of active ingredients by reducing detrimental effects.

Changes in dissolution profiles are less likely to occur in tablets made by direct compression on storage than in those made from granulations.

An added advantage to patients as they are not required to remember the timing for building up the required dosage in the human body.

Taste-masking techniques are applied to mask or overcome the bitter or unpleasant taste of active pharmaceutical ingredients/drugs to achieve patient acceptability and compliance.

Oral administration of bitter or unpleasant tasting drugs is often the biggest barrier for patient groups, such as pediatrics and geriatrics.

ZIM Labs has mastered this technology to make it not only cost-effective but also taste-mask bitter products including antibiotics, without affecting their shelf life while maintaining their dissolution and bioavailability requirements.

Pelletization, a niche technology, requires the adoption of a unique manufacturing process. Instead of the formulation being produced in powder form, the end product is in the form of fine micro granules called pellets.

Pellets give control on the time of the release of the dosage, in the required quantities in the body. The pellets are administered in capsules.

Sustained Release capsules are to be taken less than conventional dosage forms.

Dosage is released from the stomach in the body in the required proportion at the appropriate time of the day when it is required to be released, depending upon the typical disease.

An added advantage to patients as they are not required to remember the timing for building up the required dosage in the human body.

ORAL THIN FILMS

Evolution of OTF

Conventional oral solid dosage forms like tablets and capsules, in spite of their several advantages and resultant popularity, suffer from one great disadvantage, that is they have to be swallowed preferably with water or any other liquid. Voluntary swallowing is a hindrance in drug administration for children, elderly, mentally challenged, nauseated, unconscious and bedridden patients.

A need for non-obstructive dosage form possessing the other advantages of tablets has been felt constantly by the physicians and patients for many years. The concept of OTF as drug-delivering dosage forms evolved as an answer to the need for this section of patients.

Key Benefits of OTF

Improved patient compliance with ease of self-administration, storage and transportation.

Rapid dissolution, no need for water/liquids for administration.

Accurate and precise dosing. Ability to deliver small doses (milli to nano).

Relatively more useful in emergency situations such as emesis, acute pain, motion sickness, etc.

Relatively lower dosage required as it avoids the first pass metabolic pathway (when administered sublingually or buccally).

Safe and non-invasive.

Relatively lower development costs & clinical studies required as compared to developing new chemical entities/drugs.

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 trials

Sublingual/
Buccal Films

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

Qualification

5

Doctorate

81

Post Graduate

22

Graduate

03

Diploma

R&D Patents

26 Inventions with 53 filings worldwide, Registered > 190 Formulations in Various Markets

Dosage Form Modified Release Dosage Transformation Solubility Enhancement Taste Masking Total
PELLETS/CAPSULES 194----23
SUSPENSIONS ------22
TABLETS 22----4
OTF 3714--24
Total 241314253
Dosage Form Registered Applied Pipeline Total
CAPSULES 358036151
OTF 149658168
SUSPENSIONS 7151133
TABLETS 13917753369
OTHER (GEL, LIQUID, SACHETS) 3014
Total 198368159725
THE BEST INNOVATION DEVELOPMENT OF A SOLID DOSAGE FORM

AWARD AND RECOGNITION

ZIM Labs fast-dissolving OTF was awarded the best innovation development of a solid dosage form for the year 2016 by India Pharmaceutical Association.