Microneedle devices comprising peptide therapeutics and amino acids and methods of making and using same
A therapeutic agent, amino acid technology, applied in biochemical equipment and methods, medical preparations containing active ingredients, microneedles, etc.
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example 1
[0170]Sample formulations containing 10 mg / mL of PTH and 12 mg / mL of L-histidine monohydrochloride (His-HCl) in phosphate buffered saline (PBS) were prepared. The pH of the above sample formulations was 5.5-6.0. A control formulation containing 10 mg / mL of PTH in PBS was also prepared. The control formulation did not contain His-HCl. The pH of the control formulation was 6.0. Microneedle arrays were coated with the sample or control formulations described above. Coating was performed by adding 50 μL of the formulation dropwise to the portion of the array defined by the octagonal microneedle pattern. The dip-coated arrays (both sample and control formulations were coated) were dried in an oven at 35°C for approximately 15 hours.
[0171] After drying, the coated arrays were placed in a storage cabinet maintained at 40°C and 96% relative humidity (RH). The PTH content of the coated arrays was determined after storage in the chamber for 1, 3, 7 and 14 days. At indicated tim...
example 2
[0175] The same method as described in Example 1 was used except that the sample formulation contained 12 mg / mL of L-arginine hydrochloride instead of L-histidine monohydrochloride. The pH of the above sample preparation was 6.0. The results are listed in Table 2.
[0176] Table 2 :
[0177]
example 3
[0179] A sample formulation containing 5 mg / mL salmon calcitonin and 12 mg / mL L-histidine monohydrochloride (His-HCl) in PBS was prepared. The pH of the above sample preparation was 5.5. A control formulation containing 5 mg / mL salmon calcitonin in PBS was also prepared. The control formulation did not contain His-HCl. The pH of the control formulation was 6.0-6.5. Microneedle arrays were coated with the sample or control formulations described above. Coating was performed by adding 50 μL of the formulation dropwise to the portion of the array defined by the octagonal microneedle pattern. The dip-coated arrays (both sample and control formulations were coated) were dried in an oven at 35°C for approximately 15 hours.
[0180] After drying, the coated arrays were placed in a storage cabinet maintained at 40°C and 96% relative humidity (RH). The salmon calcitonin content of the coated arrays was determined after storage in the chambers for 1, 3, 7 and 14 days. At indicated...
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