WHY CONTROLLED RELEASE?
Traditionally, many products have been taken orally. Accurate dosing can be difficult and it is easy to overdose. Chewable gums and transdermals provide controlled, long-lasting delivery and have a lower potential for error and abuse.
- Improved safety through dose control and controlled release kinetics without “dose dumping”;
- Longer lasting and predictable exposure;
- Patient friendly and discreet use = client satisfaction;
- A better solution for caregivers;
- Ease of compliance with regulations and use recommendations;
- Traceability at all levels (compliance, revenue tracking and product integrity).
The images below present potential designs for controlled release transdermal patches and chewable gums.
ZHI’ patches and chewable gums will be formatted for ease of use and optimal patient/client use. The chewable gum and the transdermal patch will specify the ingredients and the bioactive dose. Each product will be traceable to its manufacturing lot and batch.
Note the convenience and easy application of the transdermal patch and the discrete, easily removable format.
- are usually applied daily and provide controlled, ongoing and overnight exposure.
- compliance with a dosing schedule is easily verified visually.
- will vary in exposure/release.
Chewable gums provide known dosing and controlled release with greater safety vs other oral presentations since they do not “dose dump”. Their convenience and ease of use provides easy day time delivery/relief. In the mouth, the ingredients are absorbed directly into the blood through the lining of the mouth (buccal and sublingual delivery). Delivery to the digestive tract is due to swallowing saliva and is a secondary pathway with lower efficacy.
Transdermal delivery devices (TDDs or patches) can provide 24 hour delivery as they rely on contact with and the natural permeability of skin. Once through the skin barrier, substances rapidly enter the capillary blood stream and are circulated throughout the body.
Both chewable gums and TDDs allow dosing to be stopped by simple removal of the dosage form.
‘Gummies’, creams and lotions can be easily overdosed and do not provide persistent release.
TDDs and chewable gums provide long lasting and predictable exposure. They lower the potential for error and abuse. They also allow a high level of traceability and accountability since tracking information can be irreversibly incorporated into individual doses. These are important features to protect product integrity from counterfeiting and can help to maintain revenues, reimbursement and compliance efforts.