Oral Testosterone Dodecanoate Composition for Safer End-Stage Therapy
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Solution Overview
Problem
Current oral testosterone therapies, such as testosterone undecanoate, pose risks of cardiovascular disease, benign prostatic hyperplasia, and prostate cancer, and have limitations in treating end-stage diseases like cirrhosis due to unfavorable pharmacokinetics and pharmacodynamics, necessitating a safer and more effective oral therapy.
Innovation Solution
Compositions and oral dosage forms of testosterone dodecanoate (TD) with specific additives to enhance bioavailability and improve therapeutic efficacy, reducing adverse events and improving health outcomes in end-stage diseases.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If oral testosterone undecanoate is used to treat end-stage diseases, then testosterone therapy can be administered orally, but it poses risks of cardiovascular disease, benign prostatic hyperplasia, and prostate cancer
Solution Approach 1:
The patent changes the chemical parameter of the testosterone ester from undecanoate (C11) to dodecanoate (C12), which fundamentally alters the pharmacokinetic profile. This parameter change results in reduced systemic absorption and lower serum testosterone levels, thereby reducing the risks of cardiovascular disease, benign prostatichyperplasia, and prostate cancer while maintaining oral administration capability
Solution Approach 2:
The patent introduces specific formulation components as intermediaries to modulate the absorption and release of testosterone dodecanoate. These formulation elements act as mediators that control the rate and extent of drug absorption, reducing peak serum concentrations and thereby minimizing adverse effects on cardiovascular and prostate health
2Reliability
If current oral testosterone therapies are used, then testosterone replacement can be achieved, but they have unfavorable pharmacokinetics and pharmacodynamics in treating end-stage diseases like cirrhosis
Solution Approach 1:
The patent changes the ester chain length parameter from C11 to C12, which optimizes the balance between absorption and metabolism. This parameter change improves pharmacokinetic profile in end-stage diseases by achieving more stable serum concentrations and better therapeutic efficacy with reduced dosing frequency
Solution Approach 2:
The patent utilizes the periodic release characteristics of testosterone dodecanoate formulation to maintain therapeutic levels over extended periods. The formulation is designed to release testosterone in a controlled periodic manner, improving reliability of testosterone replacement while accounting for altered pharmacokinetics in end-stage diseases
Data Source
AI summary
Disclosed is a method and oral composition for treating a plurality of End stage diseases such as end-stage renal disease, chronic kidney disease, liver cirrhosis, chronic liver failure, end stage liver disease, Cancer, congestive Heart failure, pulmonary fibrosis, chronic obstructive pulmonary disease. In an embodiment of the invention, the composition comprises testosterone duodecanoate.