Form-fill-seal process

Abstract

A one stage process for the preparation reservoir patches comprises feeding webs to a first pair of sealing rollers and, thence, directly to a second pair of die-cutting rollers, and preferably directly into a packaging step, thereby avoiding most operatorrelated error, and substantially increasing overall sterility and reproducibility.

Description

technical field [0001] The present invention relates to a process for forming, filling and sealing pouch products, such as depot transdermal patches, and to suitable devices for carrying out the process. Background technique [0002] Transdermal patches generally take one of two forms; matrix or depot. Matrix-type patches typically consist of an impermeable backing material that has an adhesive on one side and wherein the adhesive also includes an active material for transdermal patches. )substance. Once the patch has been applied to the skin, the active substance dissolves from the adhesive into the skin. However, such patches suffer from the dual problem of encapsulating sufficient active material in the adhesive and subsequently maintaining high levels of the active material in the adhesive without leaching into the skin. [0003] In contrast, reservoir patches have a reservoir of the active substance formed between the impermeable backing and the adhesive, which need ...

AI Technical Summary

Problems solved by technology

[0010] 2. Initial packaging is a laborious process

This feature tends to have low cycle speeds, causing production bottlenecks, incurring additional cost, and the risk of damaging the patch when it is selected for packaging

[0011] 3. Cannot incorporate tear-tab into patch during primary production

Again, this requires product alignment to keep in sync and suffers from similar drawbacks to those associated with secondary pouching

[0012] 4. The process disclosed in WO 99 / 52513 relies on contact surface clamping between horizontal jaws and vertical rollers to drive material through the process as there is no separate sheet drive unit

[0013] 5. More significantly, due to the nature of the technology, the flakes will drift throughout the process

As a result, non-destructive sampling such as by weight is unreliable and all sampling must be destructive

[0014] 6. Although the process allows flexibility in choosing patch size, load composition, machine throughput, and supply reel specifications, this flexibility is detrimental in high-volume production due to human error

Tension in thin sheets leads to inaccuracies, and the process is not suitable for liquids

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