CRD Technology Dose/Volume Attributes Drug Delivery Profile

Controlled Release Delivery Technology

Scientec's core technology is centered on the Apparatus and Methods for manufacture of Controlled Release Drug delivery ("CRD") systems. Scientec's technology provides a simple and economical method for mass production of CRD's amenable to continuous automated clean room operation. In simple terms, Scientec's technology is a continuous manufacturing process for coating drugs.

The process involves the extrusion of the coating structure onto the drug formulation using a machine the size of a desktop computer. The extrusion process first prepares the coating formulation and then coats the desired drug. Scientec has a semi automated production system capable of producing thousands of CRD's at a rate of 12 CRD's per minute.

Scientec's Apparatus and Methods are applicable to mass production of a variety of CRD's, providing a solution to problems which have previously remained unresolved. Devices that can be produced using the Scientec process include, (i) "macrocapsules", (ii) osmotic pump devices, (iii) microparticulates, and (iv) controlled release stents.

The specific application for which the Apparatus is currently being engineered is the production of delayed/controlled release implants consisting of a 'drug core' formulation coated with (and sealed inside of) layers of a biodegradable coating, i.e. macrocapsules (generally cylindrical and up to or greater than 2.5 mm in diameter and 10 mm in length). The release of the encased 'drug core' arises subsequent to degradation of the coating. The release profile of the drug substance may be either pulsatile or sustained, depending upon the pharmacokinetic properties of the drug in the solid core.

In respect of the macrocapsule implants produced using Scientec's Apparatus and Method, the technology encompasses the following features:

• the implants may be as small as a 2 mm sphere, or up to (or greater than) 3 mm diameter x 10 mm length, carrying payloads of from 5 mg to 500 mg of drug, the upper limit being an estimated ethical one
  (see additional dose and volume data)
• solid dose drug formulations are typically used, although fluid and granular based formulations can be accommodated
• demonstrated delay of release times from nil to 650 days
• reproducible batch to batch delays of release
• limited variability of delay of release within a batch of devices
• suitability for concurrent administration of multiple drugs, or multiple doses of a single drug, e.g. for the year round protection of cattle against worm infestation, or for single implant vaccines
• the drug delivery profile following the delayed release is primarily determined by the characteristics of the 'drug core' and may be tailored to accommodate pulsatile and sustained delivery
• suitable for use with FDA approved excipients
• minimal site reactivity,
• suitability for human and veterinary applications.

Additional Technical attributes and Performance details are provided in POC Trial Data.

Specific advantages of the Scientec Apparatus and Method for manufacture of CRD's include:

• continuous production method, yielding high product reliability (QC/QA and GMP conformity)
• solvent free processing, contributing to quality and reliability and avoiding any solvent residue
• cost effectiveness.

The market for Scientec's technology includes all human and veterinary pharmaceutical companies and biological (vaccine) companies, as well as generic drug companies.

 

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