Dual-Chamber Peptide Formulations for Stable Single Injection
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Solution Overview
Problem
Existing formulations of semaglutide and cagrilintide are not stable when stored together in a dual-chamber medical device, leading to particle formation during injection and the need for separate injections, which is uncomfortable and inconvenient for patients.
Innovation Solution
Developed aqueous formulations of semaglutide and cagrilintide with specific pH and buffer concentrations (semaglutide at pH 7-8 and cagrilintide at pH 3.5-4.5) that are stable during storage and administration in a dual-chamber device, allowing for a single injection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If semaglutide and cagrilintide are stored together in a dual-chamber medical device, then a single injection is enabled, but particle formation occurs and chemical stability is compromised
Solution Approach 1:
A pH 7.4 phosphate buffer is introduced as an intermediary substance in the distal chamber that mediates between the acidic cagrilintide formulation (pH 4.0) and the basic semaglutide formulation (pH 7.4). The buffer prevents direct harmful interactions while enabling co-storage, and upon injection, the local pH shift allows both drugs to remain stable during administration.
Solution Approach 2:
The patent utilizes pH parameter changes to resolve the stability issue. By formulating cagrilintide at pH 4.0 and semaglutide at pH 7.4, and introducing a pH 7.4 buffer in the distal chamber, the system maintains different pH environments for each drug during storage. Upon injection, the local pH adjustment ensures both drugs remain stable during the administration process.
2Reliability
If separate injections are administered for semaglutide and cagrilintide, then chemical stability is maintained, but patient convenience and comfort are reduced
Solution Approach 1:
The patent merges two separate injection treatments into a single combined injection by placing semaglutide and cagrilintide in separate chambers of a dual-chamber medical device. The distal chamber contains semaglutide with a pH 7.4 phosphate buffer, while the proximal chamber contains cagrilintide at pH 4.0. Both drugs are administered simultaneously through a single injection, improving patient convenience while maintaining chemical stability through spatial separation and pH-controlled environments.
3Reliability
If cagrilintide is formulated at pH 3.5-4.5, then chemical stability is improved, but compatibility with semaglutide (pH 7-8) is compromised
Solution Approach 1:
The patent segments the formulation system into two separate chambers with distinct pH environments. The proximal chamber maintains acidic conditions (pH 4.0) for cagrilintide stability, while the distal chamber maintains neutral to basic conditions (pH 7.4) for semaglutide stability. This spatial segmentation allows each drug to be formulated at its optimal pH without compromising compatibility, as the chambers remain physically separated until injection.
Solution Approach 2:
The pH 7.4 phosphate buffer in the distal chamber acts as an intermediary that protects semaglutide from the acidic environment in the proximal chamber. This buffer system maintains the pH 7.4 environment needed for semaglutide stability while allowing the acidic cagrilintide formulation to remain stable in the separate chamber, thus resolving the compatibility issue through chemical mediation.
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
Ensures chemical and physical stability of both drugs during storage and administration, reducing discomfort and improving treatment adherence by allowing a single injection, with weight loss efficacy comparable to bariatric surgery.
Implementation Method 1
a buffer which is: glutamic acid/glutamate, in a concentration of about 2-10 mM; or lactic acid/lactate, in a concentration of about 2-35 mM; or acetic acid/acetate, in a concentration of about 2-10 mM; and a pH of 3.5-4.5, preferably about pH 4.0
Data Source
AI summary
Disclosed herein are an aqueous pharmaceutical formulation comprising cagrilintide and an aqueous formulation comprising semaglutide. The compositions of these two pharmaceutical formulations allow for their presentation in, and administration using, the dual-chamber medical device disclosed herein. Individuals with diseases, such as diabetes and/or obesity and/or related co-morbidities, may benefit from the co-administration of semaglutide and cagrilintide, and/or of the two liquid pharmaceutical formulations disclosed herein, using the medical device disclosed herein.