Non-Aqueous Tylvalosin Tartrate Injection for Stability Control
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Solution Overview
Problem
There is a need for a stable pharmaceutical composition of Tylvalosin tartrate for parenteral administration to treat and prevent respiratory and enteric diseases caused by microorganisms, as existing formulations face issues with stability and dosage consistency.
Innovation Solution
A non-aqueous pharmaceutical formulation comprising Tylvalosin tartrate with adjuvants like dimethyl sulfoxide, benzyl alcohol, butylhydroxyanisole, and propylene glycol, formulated through specific mixing steps to ensure stability and effective dosage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional aqueous formulations of Tylvalosin tartrate are used, then the formulation is easy to manufacture and administer, but the stability and dosage consistency deteriorate over time
Solution Approach 1:
The patent changes the fundamental parameter of the formulation medium from aqueous to non-aqueous (using vegetable oils like sunflower, corn, or soybean oil as the base). This parameter change fundamentally improves the stability and dosage consistency of Tylvalosin tartrate while maintaining manufacturability through straightforward mixing processes.
Solution Approach 2:
The patent creates a composite formulation by combining Tylvalosin tartrate with specific adjuvants (benzyl alcohol, butylhydroxyanisole, dimethyl sulfoxide, propylene glycol) in a non-aqueous vegetable oil base. This composite approach enhances stability and dosage consistency while the specific ratio ranges provided ensure reproducibility.
2Stability of the object's composition
If stability adjuvants and non-aqueous solvents are added to improve Tylvalosin tartrate stability, then the formulation complexity increases, but the manufacturing process remains feasible
Solution Approach 1:
The patent introduces specific intermediary substances (adjuvants like benzyl alcohol, butylhydroxyanisole, dimethyl sulfoxide, and propylene glycol) that mediate between the active ingredient Tylvalosin tartrate and the non-aqueous vegetable oil base. These intermediaries enhance stability by preventing degradation while maintaining solubility and formulation homogeneity.
Solution Approach 2:
The patent specifies precise parameter ranges for each component (Tylvalosin tartrate: 5-20%, adjuvants: 0.1-10%, vegetable oil: 80-95%) to optimize stability while controlling formulation complexity. These parameter definitions enable systematic development and manufacturing.
3Object-affected harmful factors
If conventional formulations are used, then the formulation is simple, but degradation occurs particularly at elevated temperatures
Solution Approach 1:
The patent applies preliminary anti-action by incorporating stability adjuvants (particularly butylhydroxyanisole as an antioxidant and benzyl alcohol as a preservative) before exposure to degrading conditions. These adjuvants preemptively prevent degradation from occurring, especially under elevated temperature conditions during storage and administration.
Solution Approach 2:
The patent creates an inert formulation environment by using non-aqueous vegetable oils as the base medium. This inert environment protects Tylvalosin tartrate from hydrolysis and other water-mediated degradation reactions, particularly effective against thermal degradation at elevated temperatures.
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 formulation maintains Tylvalosin tartrate stability and dosage integrity, with minimal degradation over time, particularly at elevated temperatures, ensuring effective treatment and prevention of targeted diseases.
Implementation Method 1
A non-aqueous pharmaceutical formulation comprising Tylvalosin tartrate with adjuvants like dimethyl sulfoxide
Implementation Method 2
A non-aqueous pharmaceutical formulation comprising Tylvalosin tartrate with adjuvants like butylhydroxyanisole
Implementation Method 3
A non-aqueous pharmaceutical formulation comprising Tylvalosin tartrate with adjuvants like benzyl alcohol
Implementation Method 4
A non-aqueous pharmaceutical formulation comprising Tylvalosin tartrate with adjuvants like propylene glycol
Data Source
AI summary
The present invention is directed to a pharmaceutical formulation or pharmaceutical composition comprising Tylvalosin tartrate and a method of manufacturing or producing the same for injectable application and veterinary use, wherein the formulation or pharmaceutical composition is non-aqueous and contains adjuvants to stabilize the macrolide antibiotic such as Tylvalosin to be administered parenterally.