Pulmonary Formulations Using Hydrogenated Starch Hydrosylate
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Pharmaceutical formulations for pulmonary delivery face challenges in maintaining physical and chemical stability, especially during storage and administration, due to susceptibility to destabilization by environmental factors, which affects the reliability and efficacy of drug delivery.
Innovation Solution
Incorporating hydrogenated starch hydrolysate (HSH) into the formulations, particularly in the form of polyalditol, along with buffering agents like sodium citrate and amino acids, enhances the stability and bioavailability of therapeutic agents such as parathyroid hormone and budesonide, ensuring effective pulmonary delivery and storage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pharmaceutical formulations are designed for pulmonary delivery, then bioavailability is improved and pain associated with injection is avoided, but physical and chemical stability deteriorates due to susceptibility to environmental factors
Solution Approach 1:
The patent introduces HSH as an intermediary excipient that mediates between the therapeutic agent and environmental factors. HSH forms a protective matrix around the drug, acting as a buffer against humidity and temperature variations, thereby maintaining physical and chemical stability while enabling pulmonary delivery
Solution Approach 2:
The formulation uses a composite material system consisting of HSH combined with other excipients such as lactose, mannitol, or cyclodextrins. This composite structure provides synergistic effects where HSH contributes to chemical stability through its buffering capacity, while the composite formulation maintains aerosolization properties and physical stability under varying environmental conditions
2Ease of operation
If formulations are stored under adverse environmental conditions, then accessibility and ease of use are improved, but drug integrity deteriorates due to destabilization
Solution Approach 1:
The formulation incorporates HSH and other excipients that provide beforehand cushioning against adverse environmental conditions. The excipients create a protective environment within the formulation that cushions the drug from humidity, temperature fluctuations, and oxidation, allowing storage under less stringent conditions without compromising drug integrity
3Adaptability or versatility
If proteins and peptides are formulated for pulmonary delivery, then difficult-to-administer drugs become deliverable, but formulation complexity increases due to susceptibility to destabilization
Solution Approach 1:
HSH serves as an intermediary protective agent that simplifies the formulation of proteins and peptides for pulmonary delivery. By incorporating HSH, the formulation requires fewer complex stabilizing agents and processing steps, as HSH provides comprehensive protection against destabilization through its buffering capacity and protective matrix formation
Solution Approach 2:
The patent utilizes parameter changes in the excipient system, particularly HSH, to optimize formulation properties. By adjusting the type and amount of excipients including HSH, the formulation achieves optimal balance between protein stability, aerosolization characteristics, and ease of manufacture, reducing overall formulation complexity
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 use of HSH improves the chemical and physical stability of the formulations, allowing for reliable pulmonary delivery, increased bioavailability, and enhanced storability, even under adverse conditions, thereby maintaining the integrity and effectiveness of the therapeutic agents.
Implementation Method 1
The improved pharmaceutical formulations of the invention for administration to the respiratory system of a patient for the treatment, prevention and diagnosis of a variety of disease conditions comprise a mass of biocompatible particles comprising an active agent and a hydrogenated starch hydrosylate (HSH)
Data Source
AI summary
The present invention provides improved pharmaceutical formulations for pulmonary delivery having improved chemical and physical stability of the therapeutic, prophylactic or diagnostic agent as compared to formulations known in the art. The improved pharmaceutical formulations of the invention for administration to the respiratory system of a patient for the treatment of a variety of disease conditions comprise a mass of biocompatible particles comprising an active agent, and a hydrogenated starch hydrosylate (HSH). The improvement over the prior art comprises the presence of HSH in the pharmaceutical formulation. The invention further relates to a method of treating diseases comprising administering the pharmaceutical formulations of the present invention to the respiratory system of a patient in need of treatment.