Release Control mechanisms

Zero Order

The zero order release system provides a constant rate of drug release over a defined period of time. SkyePharma has four approved zero order release formulations: Paxil CR™ and Dilacor XR® in the US and Cordicant-Uno® and Requip® XL 24-Hour™ in Europe.

Binary

The binary or dual release system is used to provide the controlled release of two different drugs in a single formulation. The drugs may be released at different rates and times, if desired. This system is designed for drugs that work best in combination. SkyePharma has one binary release formulation that was approved and launched in Switzerland in the third quarter of 1997: Madopar DR®.

Bi-phasic release of drugs

Quick Slow

The quick slow release system provides a quick burst of drug release followed by a constant rate of release over a defined period of time. It is used primarily in drugs such as arthritis medications, in which it is desirable to have an initial burst of release to achieve maximum relief in a short amount of time followed by a constant rate of release for sustained therapy. SkyePharma has two approved quick slow release formulations currently on the market: diclofenac-ratiopharm® uno in Germany and ZYFLO CR™ in US.

Slow Quick

The slow quick release system provides an initial constant rate of release followed by a quick burst or faster release rate of the drug. This approach has been used for the Sular® Geomatrix™ sold in the US.

Positioned

The positioned release system is designed to deliver the tablet to a predetermined position in the digestive system before it begins to release the active drug compounds. This system is suited to drug compounds that are best absorbed by the human body at particular points in the upper gastrointestinal tract.

Accelerated

The accelerated release system provides a constantly accelerating rate of drug release. This system is suited for drugs that are preferentially absorbed in the lower part of the gastrointestinal tract.

Timed

The timed release system, also called Geoclock™, provides a predetermined time lag before it begins releasing drug molecules. This system is designed for drugs which the desired dosing time may be several hours after the patient takes the drug. SkyePharma has been developing Lodotra™, a rheumathoid arthritis drug, on behalf of Nitec. Lodotra™ is designed to deliver the active pharmaceutical ingredient at the most suitable time of day to treat the disease.

Multiple Pulse

The multiple pulse system provides an initial quick burst of drug release followed by a predetermined period of no release followed by a second burst of drug release. This system is designed for drugs that may have certain side effects, such as appetite suppression, that are desired to be minimised at predetermined times in the day, such as mealtimes.

SkyePharma PLC is a public limited company registered in England and Wales, registration number 0107582.
Registered office: 105 Piccadilly, London, W1J 7NJ, United Kingdom

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