Documentation and procedure for getting manufacturing license is nearly same as manufacturing of other pharmaceutical products read here complete process
Trans dermal patches is modern system of drug delivery. Medicine is delivered through skin by fixing transdermal patch. Transdermal patches are flexible, multi-layered preparation which is varying in size and may contain one or more pharmaceutical active ingredients to be applied to the intact skin for systemic absorption. It is formulated with adhesives that ensure adhesion of patch to the skin.
It is made-up of three layers:
- Film Backing
- Drug/Adhesive Layer
- Protecting Layer
A transdermal patch includes a backing sheet, impermeable to the active substance and normally impermeable to water. The releasing surface of the patch is covered by a protective liner to be removed before applying the patch to the skin. Transdermal patches are designed to deliver active ingredients slowly to the body through skin and assure prolong and constant absorption rate. Drug/Adhesive layer is mainly work as reservoir systems which consists three major components: drug reservoir, rate controlling membrane and adhesive.
Procedure of manufacturing:
- First step is the preparation and mixing of ingredients for patch in Mixer.
- Then liquid, adhesive matrix is applied to release liner. Most important step to ensure the uniformity & same concentration of active ingredients present at every point of patch. This stage of manufacturing process is complex and time consuming.
- This matrix is sent to drier and dried carefully and fixed to the release liner.
- After that a back layer is applied to this dried matrix. This process form a long sheet of patch that could be more 200 meter long with adequate width. This sheet is known as laminate.
- Now this laminate is sent to cutting machine to cut patched at required size.
- After cutting, each patch is packed individually and sealed into their pouches.
Types of Transdermal patches:
- Single layer Drug in adhesive
- Multi-layer Drug in adhesive
- Reservoir Patches
- Matrix Patches
- Vapour Patches
- Sliting Machine
- Slicing Machine
- Die cutting machine
- Shrink wrap
- Packing machine