Unit 6 (TDS/OTF Manufacturing Plant)
Shilpa Medicare Limited has it’s state-of-the-Art, fully automated facility meeting all the regulatory standards for development and manufacturing of Transdermal patches and Oral Thin films. This site is built to comply the requirements of all global Regulatory Markets.
OTF (Oral Thin Films)
An Oral Thin Film (OTF), composed of a mono or multi-layer polymeric matrix, is a modern expansion in drug delivery and designed for comfort and compliance. OTF are water based soluble polymers intend to rapidly deliver drugs systematically. Depending on the drug candidate and the targeted indication, OTF can be formulated either as:
OTF works like conventional orodispersible tablets. In this case OTF dissolves within seconds in the mouth and the drug substance is swallowed together with the saliva and takes the same route as a tablet.
OTF can be manufactured as a Trans mucosal film, where the active substance directly enters the systemic circulation via the buccal mucosa, avoiding the hepatic first pass effect. The active ingredient can be either dissolved or suspended in the polymeric matrix.
TDS (Transdermal System):
Transdermal patches are designed to deliver drugs systemically and has many advantages over other conventional routes of drug delivery.
Transdermal patches are typically composed of a single or multi-layer polymeric adhesive matrix, one of the layer containing the drug substance dissolved or in suspension in the matrix. This matrix is sandwiched between a backing film and a release liner, the release liner being removed before application and the backing film staying on the patch as a protective support.
The transdermal route offers key advantages over oral administration:
- - Avoidance of the hepatic first-pass effect leading to better bioavailability and fewer side effects for molecules with low oral bioavailability.
- - Sustained drug delivery over the application, avoiding potential drug peaks and periods of over and under-dosing, therefore allowing for reduced dosing frequency.
- - In some therapeutic areas and for certain patient populations (ex: older patients with multiple-medications, patients with swallowing difficulty) transdermal patches, which are self-administered, allow to decrease the pill burden and provide longer intervals between doses with an easy administration, leading to increased patient compliance.
Shilpa Medicare’s state of art facility has all critical process equipments, besides others our manufacturing line is equipped with different coating methods. Our in-house capability offers variable coating widths between 120mm and 540 mm; in order to match volume requirements.
Our packaging capabilities of transdermal patches and oral thin films offers a combination of both specific and flexible packaging lines to allow diverse formats going from small to big sizes units and allowing various patterns.
Converting of web into its final dosage form is also critical as it decides the dose accuracy. Shilpa Medicare have high-tech converting machine with inbuilt rejection handling.
Our capacity is designed to produce around 40 million products per Year and facility is fully equipped with state-of-the-art instruments to evaluate all kinds of testing of both Oral Thin Films and Transdermal Patch formulations. Facility is certified by the GMP consultants.
Customer satisfaction is of utmost importance, we ensure that customer’s needs are met using high service standards for existing and new products:
- - We put a constant priority on having strict compliance with worldwide standards in manufacturing, quality, safety and environment.
- - We manage end to end supply chain including contractor supply chain management.
- - We deliver products offering the best quality, cost and service.