The TIMERx® oral controlled release delivery system allows Penwest to modify the release of drugs to provide a therapeutic benefit to patients by delivering medicines that are more efficacious and provide greater patient compliance. The technology is cost-effective and easy to scale-up and manufacture.
This sophisticated yet simple delivery technology precisely and predictably controls drug release and can provide a range of benefits - reduce dosing frequency, improve drug performance and compliance, minimize side effects, achieve new indications, and optimize the performance of chemical entities.
The TIMERx oral drug delivery system achieves a variety of release profiles (First order, Zero order, BurstCR, etc.) for a wide range of drugs, accommodating even the most difficult actives.
TIMERx can be used in:
TIMERx enables Penwest to meet the significant challenges of today's pharmaceutical marketplace head-on with 32 U.S. issued patents and 178 patents worldwide.
TIMERx® Provides Significant Advantages Throughout the Drug Development Process
The TIMERx technology provides development benefits as well as clinical benefits.
Development Benefits
Clinical Benefits
Geminex® is a unique dual drug delivery technology that provides independent release of combined active ingredients. It is a unique bi-layer, dual-release tablet technology that can deliver two different and unique release profiles for one or more drugs.
The Geminex dual drug delivery technology controls the release rate of each component to maximize its individual therapeutic effect and minimize its side effects. The Geminex technology can deliver a medication that is therapeutically superior to its individual components.
Complementary mechanisms of action in combined therapy provide treatment benefits in major disease states:
The Geminex® dual-release technology is a second generation technology that has evolved from the TIMERx® technology platform. Its heritage combines maximum dual-release versatility with the speed to formulate and cost-effectiveness of the TIMERx technology. Penwest believes the ultimate result of the application of Geminex to Penwest's product concepts results in superior products with a speed-to-market advantage.
Because Geminex has evolved from the TIMERx technology platform, it provides many of the same development and clinical benefits as does TIMERx (see TIMERx section), while also offering additional benefits when compared to other dual drug delivery technologies. The additional benefits are the following:
Maximum Efficacy
Geminex can improve the therapeutic benefits of drugs and reduce side effects by delivering two drugs with complementary mechanisms of action. The technology is particularly effective for disease states such as diabetes, hypertension, depression, pain, etc.
Flexible and Versatile System that can Achieve a Variety of Release Profiles for a Wide Range of Drugs:
Fast, Easy, Cost-effective Production
The Geminex® technology is a second generation technology that has evolved from the TIMERx® technology platform. Due to Geminex's heritage, drug release rates are controlled by a customized, agglomerated hydrophilic complex that forms a controlled-release matrix upon compression. The matrix consists of two polysaccharides, xanthan and locust bean gum. Interactions between these components in an aqueous environment form a tight gel with a slowly eroding core.
A major advantage of the Geminex technology is the ability to develop a combination drug product that has two unique release profiles. To achieve the unique release profiles different custom granulations are made for each drug component. The two drugs are then compressed on a standard bi-layer press.
SyncroDoseTM is a novel enabling technology that uses Penwest's unique TIMERx® patented agglomerated hydrophilic matrix system.
SyncroDose is the first technology that offers a variety of predetermined lag times, that can control when and where a drug is released, followed by a variety of customized drug-release profiles to include immediate and controlled release.
Some of the disease states that may benefit from chronotherapy are:
It's about when...
SyncroDose works with the body's biological clock to customize the delivery of drug, reduce dose and improve efficacy
It's about where...
Different SyncroDose formulations provide the ability to deliver the drug to different sites within the gastro-intestinal tract
SyncroDoseTM Provides Significant Advantages
By administering drug at the optimal time after ingestion, SyncroDose can potentially improve the therapeutic benefit of drugs or reduce the dose needed to provide a given therapeutic effect. If a reduction in dose occurs, the side effects of the drug may also be reduced or lessened in severity.
A SyncroDose tablet consists of an inner core of drug and a surrounding compression coating containing TIMERx® based materials. Lag time is controlled by variations in the two polysaccharides, xantham gum and locust bean gum, found in the TIMERx coating.
How Does SyncroDoseTM Control Drug Release?
This delivery system works by controlling the rate of water ingress into the coating and subsequent disintegration of the core. Modification of this coating layer can be made to control the rate of release of drug, i.e., extent of lag time and release profile of drug.
SyncroDoseTM Control Drug Release image demonstrates through animation the gamma image obtained for the referenced scinitigraphy study and illustrates the erosion and subsequent release of the coating (blue) from the core (green) throughout the gastrointestinal tract over time.
A - Within a few minutes of administration, the SyncroDose tablet enters the stomach. At this point in time, the outer polysaccharide based coating, shown in blue, begins to swell. The tablet core, represented by the green area, remains intact.
B - Over time, the tablet moves along the gastrointestinal tract through the pylorus and into the duodenum. The coating erosion process continues. The tablet core exhibits slower transit and remains subsequently in its entirety.
C - After approximately 3.5 hours, the coat erosion process is completed, exposing the core to the intestinal environmental conditions. Upon exposure, the core bursts open almost immediately and the disintegration process is complete within a few minutes. Following the rapid burst, the drug component of the core becomes available for immediate dissolution and absorption.
Scinitigraphy data for both the coating and core of a SyncroDose Tablet
The following sets of image illustrate independently and with greater detail the in vivo performance of the SyncroDose tablet's core and coat. The tablet core is radiolabelled with ER-171 (0.5MBq) and the compression coating is radiolabelled with Sm-153 (1.5MBq). Click here to view the detailed image with captions.
How Does SyncroDose Work Over Time?
A combination of the time of administration and the body's biologic clock enables the customization of drug delivery to optimize both dose and efficacy.
Results from this pharmacoscintigraphy study demonstrate a customized delivery of drug whereby maximum plasma levels are achieved after five hours, preceded by a predetermined lag time. An excellent in vitro/in vivo correlation was observed.
To view the charts, select Average Blood Plasma Data or In Vitro Dissolution Data.
SyncroDoseTM is a novel enabling technology that utilizes Penwest's TIMERx® agglomerated hydrophilic matrix system to allow drugs to be delivered after predetermined lag times to coincide with the body's circadian rhythm pattern or to allow drugs to be delivered to different sites within the gastrointestinal tract.
A SyncroDose tablet consists of an inner core of drug and a surrounding compression coating containing TIMERx-based materials. Lag time is controlled by variations in the two polysaccharides, xanthan gum and locust bean gum.
SyncroDose works by controlling the rate of water ingress into the coating and subsequent erosion of the external polysaccharide-containing layer. The rate of release can be controlled by the modification of the coating layer.
GastroDose is a gastro retentive drug delivery system which enables the retention of an oral solid dosage form in the stomach or upper gastro intestinal (GI) tract for a prolonged period of time. We believe this technology benefits drugs that have a narrow window of absorption in the stomach and upper GI tract.
How does the GastroDose Drug Delivery System work?
GastroDose causes tablets to swell in the stomach, preventing their passage into the lower GI tract for several hours. During this time, the drug diffuses out of the tablet and is delivered in the upper GI tract.
Potential Advantages of the GastroDose Drug Delivery System include:
– increased drug bioavailability
– increased efficacy
– reduced side effects
– extended time intervals between dosing
– increased patient compliance
TIMERx enables Penwest to meet the significant challenges of today's pharmaceutical marketplace head-on with 32 U.S. issued patents and 200 patents worldwide.
OUr technoogy is ready for product development and licensing.
Carlos Velez
Director, Business Development and Licen
Penwest is a specialty pharmaceutical company dedicated to bringing to the marketplace innovative products that help improve the lives of patients.
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