Treatment of bone fractures and defects
a bone fracture and defect technology, applied in the field of treatment, can solve problems such as the problematic oral administration of peptide pharmaceuticals, and achieve the effect of reducing the frequency of oral administration and reducing the dose of parathyroid hormon
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example 1
Pharmacokinetic Profile of Orally Administered Parathyroid Hormone (PTH)
[0591]Pharmacokinetic Study Design:
[0592]An open label comparative pharmacokinetic study was performed in healthy volunteers over the course of 3 months. Each volunteer received—in each of two visits—the same oral tablet containing 0.75 mg of teriparatide, a recombinant form of parathyroid hormone (1-34).
[0593]The formulation was composed of teriparatide (0.75 mg), SNAC (sodium 8-N-(2-hydroxybenzoyl) aminocaprylate), soybean trypsin inhibitor (SBTI) and a small amount of magnesium stearate.
[0594]Tablets were administered in the morning after an 8-hour overnight fast and immediately followed by 150 ml of water. At each visit a standard meal was provided 3 hours after drug administration. Patients did not eat or drink alcoholic or caffeinated beverages. There was a two weeks period between the visits.
[0595]To determine parathyroid hormone(1-34) (PTH(1-34)) concentrations, blood samples (4 ml each) were drawn via a...
example 2
Phase I Clinical Trial of Orally Administered Parathyroid Hormone (PTH)
[0600]A Phase I clinical study of exemplary oral formulations comprising teriparatide (parathyroid hormone (1-34)) was conducted at the Hadassah Clinical Research Center. 42 healthy volunteers were included throughout the study.
[0601]The formulation was composed of teriparatide (200, 400, 680, 1400 or 1800 μg), SNAC (sodium 8-N-(2-hydroxybenzoyl) aminocaprylate), soybean trypsin inhibitor and magnesium stearate.
[0602]Tablets were administered in the morning after an 8-hour overnight fast and immediately followed by 150 ml of water. At each visit a standard meal was provided 3 hours after drug administration. Patients did not eat or drink alcoholic or caffeinated beverages.
[0603]To determine parathyroid hormone concentrations, blood samples (4 ml each) were drawn via an indwelling catheter from the forearm vein at predetermined time points. The cannula was flushed with 1.5 ml normal saline after each sampling. In ...
example 3
Casing Containing Parathyroid Hormone and Swellable Substance
[0611]A drug delivery system comprising a casing encapsulating active ingredients, parathyroid hormone and SNAC (sodium 8-N-(2-hydroxybenzoyl)aminocaprylate) (per se, or formulated as a pharmaceutical composition according to any of the respective embodiments described herein) according to some embodiments of the invention is optionally assembled as depicted in FIG. 12.
[0612]A first casing component (A) is filled with substance which swells upon contact with water (B), followed by a barrier (C), and active ingredients (parathyroid hormone and SNAC) (D), optionally in granular form. A second casing component (E) is then placed in contact with first casing component (A), thereby encapsulating (B), (C) and (D). A layer of enteric polymer (not shown) as described herein in any of the respective embodiments, is then formed over at least a portion of an external surface of casing components (A) and (E). Adhesion of the layer to ...
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