Apparatus and method for transdermal delivery of parathyroid hormone agents
A kind of drug and transdermal technology, applied in the direction of drug equipment, medical science, surgery, etc., can solve problems such as difficulties, discomfort, and poor patient compliance
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Embodiment 1
[0205] Release of hPTH(1-34) from coated microprojection arrays was evaluated using the hairless guinea pig (HGP) model. Microprojection arrays were fabricated using photo / chemical etching and patterning. The microprojection array used in this study has an area of 2 cm 2 , 320 microprojections / cm 2 , the jet body length is 200 μm. The microprojection array was divided into 25% aqueous solution of hPTH(1-34) every 2cm 2 Arrays were 40 ± 10 μg coated, with solid coating limited to the first 100 μm of the microprojections. Each coated microprojection array was mounted with a flexible polymeric adhesive backing. The resulting patch was placed on a ring positioner and onto a reusable impact applicator when applied to the HGP.
[0206] Each anesthetized HGP received the patch, which was applied to a clean skin area for 1 hour. At various time intervals after patch application, blood samples were taken. hPTH(1-34) plasma levels were determined by enzyme immunoassay (Peninsul...
Embodiment 2
[0214] Example 2 demonstrates that hPTH(1-34) drugs increase viscosity using weak acids. The interaction of the weak acid anion with the positively charged hPTH(1-34) drug leads to the formation of secondary bonds, such as hydrogen bonds, which lead to an increase in solution viscosity. The greater the number of acidic groups, the greater the number of second bonds formed between the anion and the hPTH(1-34) drug, and thus the greater the increase in viscosity. Therefore, when comparing monobasic acids, dibasic acids, tribasic acids, and tetrabasic acids, the theoretical viscosity increasing ability increases.
[0215] In this test, hPTH(1-34) preparations were spiked with various weak acid buffers. A control formulation including PTH(1-34) acetate and sucrose was also prepared. This test investigated the physicochemical properties provided by various mixtures of hPTH(1-34) with mono-, di-, and tri-acids, and the stability of solution formulations at 2-8°C for 48 hours. The...
Embodiment 3
[0221] Example 3 demonstrates that hPTH(1-34) drugs use counter ion mixtures to enhance the in vivo dissolution of hPTH-based drugs.
[0222] In solid coatings on microprojection arrays, the drug is generally present in an amount of less than about 1 mg per unit dose. After adding excipients and counter ions, the total mass of the solid coating can be less than 3 mg per unit dose.
[0223] The array is typically present on an adhesive backing that is adhered to a disposable polymeric ring retainer. The combination is typically individually packaged in a sachet or polymer casing. In addition to the combination, the package contains an atmosphere (usually inert) providing a volume of at least 3 ml. This large volume (compared to the coating volume) acts as an absorber for any volatile components. For example, at 20°C, the amount of acetic acid present in 3ml of atmosphere due to its vapor pressure is about 0.15mg. If acetic acid is used as the counterion, this amount will ge...
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