Journal: Pharmaceutics

Article Title: Human Growth Hormone Delivery with a Microneedle Transdermal System: Preclinical Formulation, Stability, Delivery and PK of Therapeutically Relevant Doses

doi: 10.3390/pharmaceutics6020220

Figure Lengend Snippet: Transdermal microneedle patch delivery system ( a ) 5 cm 2 adhesive patch with microneedle array (3 cm 2 ) in applicator ring; ( b ) Zosano Pharma (ZP)-Patch press fit onto the bottom of the applicator; and applicator; ( c ) 60× magnification of recombinant human growth hormone (rhGH) coated microneedles (580 microneedles/cm 2 , length 340 µm and tip angle 60°), rhGH coated at 0.5 mg/3 cm 2 array; and ( d ) Front view of an individual rhGH coated microneedle (250× magnification).

Article Snippet: Recombinant human growth hormone (rhGH) at a concentration of 13 mg/mL with 19 mM sodium phosphate buffer, 13.3 mg/mL glycine and 66 mg/mL mannitol was purchased from AMEGA Biotech (Buenos Aires, Argentina). rhGH activity was 3 IU/mg.

Techniques: Adhesive, Recombinant

Journal: Pharmaceutics

Article Title: Human Growth Hormone Delivery with a Microneedle Transdermal System: Preclinical Formulation, Stability, Delivery and PK of Therapeutically Relevant Doses

doi: 10.3390/pharmaceutics6020220

Figure Lengend Snippet: Shear stress vs. shear rate for 20% w / w rhGH, 20% w / w sucrose, 0.2% w / w polysorbate 20 liquid formulation. Shear stress is proportional to shear rate suggesting Newtonian behavior for the rhGH liquid formulation.

Article Snippet: Recombinant human growth hormone (rhGH) at a concentration of 13 mg/mL with 19 mM sodium phosphate buffer, 13.3 mg/mL glycine and 66 mg/mL mannitol was purchased from AMEGA Biotech (Buenos Aires, Argentina). rhGH activity was 3 IU/mg.

Techniques: Shear, Formulation

Journal: Pharmaceutics

Article Title: Human Growth Hormone Delivery with a Microneedle Transdermal System: Preclinical Formulation, Stability, Delivery and PK of Therapeutically Relevant Doses

doi: 10.3390/pharmaceutics6020220

Figure Lengend Snippet: Stability of rhGH-coated microneedle system where the 3 cm 2 titanium microneedle array was coated with 0.5 mg dose, assembled on a 5 cm 2 adhesive patch within a polycarbonate retainer ring with co-molded desiccant, and heat sealed in a nitrogen-purged foil pouch. The final rhGH-coated microneedle packaged systems were stored at 40 °C/75% RH (relative humidity).

Article Snippet: Recombinant human growth hormone (rhGH) at a concentration of 13 mg/mL with 19 mM sodium phosphate buffer, 13.3 mg/mL glycine and 66 mg/mL mannitol was purchased from AMEGA Biotech (Buenos Aires, Argentina). rhGH activity was 3 IU/mg.

Techniques: Adhesive

Journal: Pharmaceutics

Article Title: Human Growth Hormone Delivery with a Microneedle Transdermal System: Preclinical Formulation, Stability, Delivery and PK of Therapeutically Relevant Doses

doi: 10.3390/pharmaceutics6020220

Figure Lengend Snippet: Comparison of the purity of rhGH active pharmaceutical ingredient (API) prior to processing and ZP-hGH patch after storage at 40 °C/75% RH for 6 months.

Article Snippet: Recombinant human growth hormone (rhGH) at a concentration of 13 mg/mL with 19 mM sodium phosphate buffer, 13.3 mg/mL glycine and 66 mg/mL mannitol was purchased from AMEGA Biotech (Buenos Aires, Argentina). rhGH activity was 3 IU/mg.

Techniques: Comparison

Journal: Pharmaceutics

Article Title: Human Growth Hormone Delivery with a Microneedle Transdermal System: Preclinical Formulation, Stability, Delivery and PK of Therapeutically Relevant Doses

doi: 10.3390/pharmaceutics6020220

Figure Lengend Snippet: Pharmacokinetic (PK) profile of rhGH delivered by microneedle patch or SC injection: ZP-hGH patch ( 0.5 mg and 1 mg); Norditropin ® SC injection 0.4 mg, 0.8 mg and 1.4 mg).

Article Snippet: Recombinant human growth hormone (rhGH) at a concentration of 13 mg/mL with 19 mM sodium phosphate buffer, 13.3 mg/mL glycine and 66 mg/mL mannitol was purchased from AMEGA Biotech (Buenos Aires, Argentina). rhGH activity was 3 IU/mg.

Techniques: Injection

Journal: Pharmaceutics

Article Title: Human Growth Hormone Delivery with a Microneedle Transdermal System: Preclinical Formulation, Stability, Delivery and PK of Therapeutically Relevant Doses

doi: 10.3390/pharmaceutics6020220

Figure Lengend Snippet: rhGH plasma concentration of ZP-hGH patch at 0.5 mg and 1 mg doses ( ) vs. Norditropin ® SC injection over the range of 0.4 to 1.4 mg ( ).

Article Snippet: Recombinant human growth hormone (rhGH) at a concentration of 13 mg/mL with 19 mM sodium phosphate buffer, 13.3 mg/mL glycine and 66 mg/mL mannitol was purchased from AMEGA Biotech (Buenos Aires, Argentina). rhGH activity was 3 IU/mg.

Techniques: Clinical Proteomics, Concentration Assay, Injection