Electron Beam Sterilization of Hypercompressed Polymer Dosage Forms
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Solution Overview
Problem
Hypercompressed biologically compatible polymers and copolymers used in pharmaceutical formulations are susceptible to degradation when sterilized with radiation, leading to reduced potency and stability issues, particularly when containing thermally unstable APIs like proteins or polypeptides, which fail to meet regulatory standards.
Innovation Solution
The use of electron beam sterilization for hypercompressed pharmaceutical formulations made with ester capped lactide, glycolide, or lactide-glycolide copolymers avoids the degradation issues associated with gamma radiation, allowing for the production of sterile, stable products without compromising the API's integrity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If gamma radiation is used to sterilize hypercompressed polymeric pharmaceutical formulations, then sterilization is achieved, but the polymeric material and API are degraded or denatured
Solution Approach 1:
The patent changes the radiation parameter from gamma radiation to electron beam radiation. This parameter change allows sterilization to be achieved while avoiding the degradation and denaturation problems associated with gamma radiation, thereby maintaining both sterilization effectiveness and material stability.
2Productivity
If hypercompression is applied to densify polymeric microspheres containing API, then controlled release formulation is formed, but radiation-induced degradation is facilitated due to closer proximity of reactive species
Solution Approach 1:
The patent changes the radiation type parameter from gamma to electron beam, which resolves the contradiction by enabling sterilization of hypercompressed formulations without exacerbating degradation. The electron beam radiation achieves sterilization while minimizing the harmful effects on the densely packed reactive species in hypercompressed formulations.
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
Electron beam sterilization effectively reduces radiation-induced degradation byproducts, ensuring the stability and potency of the API, meeting regulatory standards for pharmaceutical use and extending the shelf life of the product.
Implementation Method 1
The use of electron beam sterilization for hypercompressed pharmaceutical formulations made with ester capped lactide, glycolide, or lactide-glycolide copolymers avoids the degradation issues associated with gamma radiation
Implementation Method 2
ionizing radiation interacts with the electrons of polymer molecules with a transfer of energy that results in ion formation and ejection of secondary electrons
Implementation Method 3
when gamma radiation is applied to make a sterile product based on a polymeric material comprising a lactide polymer, glycolactide or lactide-glycolactide copolymer, these polymeric materials and any polypeptide or protein, which is present, may be degraded or denatured
Implementation Method 4
The immediate outcome of the exposure to ionizing radiation, such as gamma radiation, is the formation of various energetic species such as trapped radicals, electrons and ions; the decays of these energetic species results in fragmentation and generates free radicals
Implementation Method 5
hypercompressed (densified) biologically compatible lactide polymer, glycolactide or lactide-glycolactide copolymers containing APIs
Data Source
AI summary
A sterile pharmaceutical dosage form which comprises an ester capped lactide polymer, glycolide polymer or a lactide-glycolide copolymer hypercompressed with an active pharmaceutical ingredient wherein said sterile pharmaceutical dosage form has been sterilized with an electron beam and a method of preparing said sterile pharmaceutical dosage form.