Table 29 Levels of sub-visible particles in citrate-buffered cagrilintide and semaglutide co-formulations containing HP-B-CD excipients of varying hydroxypropyl molar substitution degree 1 MS: molar substitution, corresponds to hydroxypropyls per glucose unit Table 30 Levels of HMWP in citrate-buffered cagrilintide and semaglutide coformulations containing HP-B-CD excipients of varying hydroxypropyl molar substitution degree 1 MS: molar substitution, corresponds to hydroxypropyls per glucose unit Table 31 Chemical purity (%) of semaglutide in citrate-buffered cagrilintide and semaglutide co-formulations containing HP-B-CD excipients of varying hydroxypropyl molar substitution degree 1 MS: molar substitution, corresponds to hydroxypropyls per glucose unit Concluding Remarks The results presented in tables 29, 30, and 31 show that the physical stability, the formation of HMWP, and the chemical purity of semaglutide is dependent on the molar substitution of the HP-B-CD when studied in a citrate-buffered cagrilintide and semaglutide co-formulation
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A further possible limitation is the low statistical power used in the calculation of the sample size
