Thyroid Manufacturing Process for Controlled Hormone Ratios
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Solution Overview
Problem
Current thyroid manufacturing processes fail to consistently produce a product that is free of viral and bacterial contaminants and has a controlled T4/T3 hormone ratio, which is essential for effective thyroid replacement therapies.
Innovation Solution
A novel thyroid manufacturing process involving the mincing of porcine thyroid glands, followed by multiple acetone washes, filtration, drying at temperatures between 80° C. and 95° C. for at least 6 hours, milling, and homogenization with excipients like lactose to achieve a product with undetectable viral and bacterial loads and a controlled T4/T3 ratio.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional thyroid manufacturing processes are used, then production is simpler and faster, but the product contains viral and bacterial contaminants and has uncontrolled T4/T3 hormone ratios
Solution Approach 1:
The manufacturing process is divided into distinct sequential stages: mincing, multiple acetone wash cycles, filtration, extended drying at controlled temperature (80-95°C for至少6 hours), milling, and homogenization. Each stage targets specific contaminants or process control parameters, with the segmentation allowing systematic elimination of viruses and bacteria while controlling hormone ratios through precise process parameters
Solution Approach 2:
The process performs preliminary actions to prevent contamination and ensure quality before final product formation. Multiple acetone washes are performed before drying to remove contaminants, and extended drying at controlled temperature is performed before milling to ensure complete moisture removal and hormone stabilization. These preliminary actions prevent the need for complex post-processing quality control
2Object-affected harmful factors
If extended drying at 80-95°C for at least 6 hours is performed, then viral and bacterial contaminants are eliminated, but energy consumption and processing time increase
Solution Approach 1:
The drying process uses optimized parameter ranges: temperature is maintained within 80-95°C (not higher to avoid hormone degradation, not lower to ensure contaminant elimination), and duration is set to at least 6 hours. This parameter optimization achieves complete viral and bacterial elimination while minimizing energy consumption and preventing hormone degradation that would occur at higher temperatures or extended times
Solution Approach 2:
The extended drying time and controlled temperature, which initially appear to be energy-intensive measures, actually serve to eliminate the need for additional sterilization steps and complex quality control processes. The thorough drying prevents microbial regrowth and stabilizes hormones, converting what appears to be a disadvantage (long processing time) into a benefit (reduced need for additional processing steps)
3Reliability
If multiple acetone wash cycles and extended drying are performed, then the product is free of contaminants, but the manufacturing cost increases
Solution Approach 1:
The process uses acetone, a volatile solvent, which serves a dual function: it effectively removes viral and bacterial contaminants during washing, and then automatically evaporates during the subsequent extended drying phase without requiring additional removal steps. The drying process simultaneously removes moisture and residual acetone, making the system self-service and eliminating the need for complex solvent recovery or additional washing steps
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The process results in a thyroid product with a T4/T3 ratio between 4.0 and 4.6 and ensures the absence of viral and bacterial contaminants, meeting stringent quality standards for thyroid replacement hormones.
Implementation Method 1
filtered
Implementation Method 2
dried at a temperature that ranges between 80° C. and 95° C., during at least 6 hours
Implementation Method 3
milled
Implementation Method 4
Homogenization of the milled product from step ii) with an excipient selected from lactose, maltodextrin, xylitol, lactitol, mannitol, among others, to dilute the hormones
Data Source
AI summary
The invention relates to a thyroid manufacturing process, and more particularly, to a novel thyroid manufacturing process which encompasses a new drying step during the thyroid extraction step and a further homogenization, which allow in a thyroid product with a controlled value of hormones, and it is essentially free of virus and bacteria.