Nasal Administration and Plasma Pharmacokinetics of Parathyroid Hormone Peptide PTH 1-34 for the Treatment of Osteoporosis.

Pearson RG, Masud T, Blackshaw E, Naylor A, Hinchcliffe M, Jeffery K, Jordan F, Shabir-Ahmed A, King G, Lewis AL, Illum L, Perkins AC

Pharmaceutics7 Jun 2019Cited by 19 (Europe PMC)

PMID31181662PMCIDPMC6631119DOI10.3390/pharmaceutics11060265PepBankPUB-31181662

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Summary

Nasal delivery of large peptides such as parathyroid 1-34 (PTH 1-34) can benefit from a permeation enhancer to promote absorption across the nasal mucosa into the bloodstream. Previously, we have published an encouraging bioavailability (78%), relative to subcutaneous injection in a small animal preclinical model, for a liquid nasal spray formulation containing the permeation enhancer polyethylene glycol (15)-hydroxystearate (Solutol^® HS15). We report here the plasma pharmacokinetics of PTH 1-34 in healthy human volunteers receiving the liquid nasal spray formulation containing Solutol^® HS15. For comparison, data for a commercially manufactured teriparatide formulation delivered via subcutaneous injection pen are also presented. Tc-99m-DTPA gamma scintigraphy monitored the deposition of the nasal spray in the nasal cavity and clearance via the inferior meatus and nasopharynx. The 50% clearance time was 17.8 min (minimum 10.9, maximum 74.3 min). For PTH 1-34, mean plasma C_max of 5 pg/mL and 253 pg/mL were obtained for the nasal spray and subcutaneous injection respectively; relative bioavailability of the nasal spray was ≤1%. Subsequently, we investigated the pharmacokinetics of the liquid nasal spray formulation as well as a dry powder nasal formulation also containing Solutol^® HS15 in a crossover study in an established ovine model. In this preclinical model, the relative bioavailability of liquid and powder nasal formulations was 1.4% and 1.0% respectively. The absolute bioavailability of subcutaneously administered PTH 1-34 (mean 77%, range 55-108%) in sheep was in agreement with published human data for teriparatide (up to 95%). These findings have important implications in the search for alternative routes of administration of peptides for the treatment of osteoporosis, and in terms of improving translation from animal models to humans.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study6

3 results from studies that gave the peptide. 2 results from people.

01HumanNon-randomized trialPharmacokinetics
In healthy volunteers, nasal PTH reached a mean plasma Cmax of 5 pg/mL.
In plain wordsIn healthy volunteers, nasal PTH reached a mean peak blood level of 5 pg/mL.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableNasal PTH Cmax
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · nasalAs given in this study (human).
Measurements
Cmax
5 pg/mL
nasal spray
Source sentences
Summary
For PTH 1-34, mean plasma C_max of 5 pg/mL and 253 pg/mL were obtained for the nasal spray and subcutaneous injection respectively; relative bioavailability of the nasal spray was ≤1%.
1 context sentence(design, population, supporting numbers)
Summary · context
We report here the plasma pharmacokinetics of PTH 1-34 in healthy human volunteers receiving the liquid nasal spray formulation containing Solutol^® HS15.
Show in the study text Report a problemFND-3118166201
02HumanNon-randomized trialPharmacokinetics
In healthy volunteers, subcutaneous PTH reached a mean plasma Cmax of 253 pg/mL.
In plain wordsIn healthy volunteers, injected PTH reached a mean peak blood level of 253 pg/mL.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableSubcutaneous PTH Cmax
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Measurements
Cmax
253 pg/mL
subcutaneous injection
Source sentences
Summary
For PTH 1-34, mean plasma C_max of 5 pg/mL and 253 pg/mL were obtained for the nasal spray and subcutaneous injection respectively; relative bioavailability of the nasal spray was ≤1%.
2 context sentences(design, population, supporting numbers)
Summary · context
For comparison, data for a commercially manufactured teriparatide formulation delivered via subcutaneous injection pen are also presented.
Summary · context
We report here the plasma pharmacokinetics of PTH 1-34 in healthy human volunteers receiving the liquid nasal spray formulation containing Solutol^® HS15.
Show in the study text Report a problemFND-3118166202
03AnimalAnimal study (in vivo)Pharmacokinetics
In sheep, subcutaneous PTH absolute bioavailability averaged 77%, with a range of 55-108%.
In plain wordsIn sheep, injected PTH had average absolute bioavailability of 77%.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableSubcutaneous absolute bioavailability
Study
sheepn: not reported in source
Ovine pharmacokinetic model
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · subcutaneousAs given in this study (sheep).
Measurements
Absolute bioavailability
77%
mean
Absolute bioavailability
55 to 108%
range
Source sentences
Summary
The absolute bioavailability of subcutaneously administered PTH 1-34 (mean 77%, range 55-108%) in sheep was in agreement with published human data for teriparatide (up to 95%).
Show in the study text Report a problemFND-3118166206

Studies that did not test the peptide alone3

In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Teriparatide (PTH 1-34).

04HumanNot a test of Teriparatide (PTH 1-34) aloneNon-randomized trialPharmacokinetics
In healthy volunteers, nasal PTH relative bioavailability was ≤1% compared with subcutaneous injection.
In plain wordsIn healthy volunteers, nasal PTH bioavailability was ≤1% relative to injection.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableNasal relative bioavailability
Study
n: not reported in source
Comparator
Subcutaneous injection
Outcome group
Pharmacokinetics · Pharmacology
Measurements
Relative bioavailability
≤ 1%
nasal spray
Source sentences
Summary
For PTH 1-34, mean plasma C_max of 5 pg/mL and 253 pg/mL were obtained for the nasal spray and subcutaneous injection respectively; relative bioavailability of the nasal spray was ≤1%.
1 context sentence(design, population, supporting numbers)
Summary · context
We report here the plasma pharmacokinetics of PTH 1-34 in healthy human volunteers receiving the liquid nasal spray formulation containing Solutol^® HS15.
In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Teriparatide (PTH 1-34).
Show in the study text Report a problemFND-3118166203
05AnimalNot a test of Teriparatide (PTH 1-34) aloneAnimal study (in vivo)Pharmacokinetics
In sheep, liquid nasal PTH had relative bioavailability of 1.4%.
In plain wordsIn sheep, liquid nasal PTH had relative bioavailability of 1.4%.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableLiquid nasal relative bioavailability
Study
sheepn: not reported in source
Ovine crossover pharmacokinetic model
Outcome group
Pharmacokinetics · Pharmacology
Measurements
Relative bioavailability
1.4%
liquid nasal formulation
Source sentences
Summary
In this preclinical model, the relative bioavailability of liquid and powder nasal formulations was 1.4% and 1.0% respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Subsequently, we investigated the pharmacokinetics of the liquid nasal spray formulation as well as a dry powder nasal formulation also containing Solutol^® HS15 in a crossover study in an established ovine model.
In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Teriparatide (PTH 1-34).
Show in the study text Report a problemFND-3118166204
06AnimalNot a test of Teriparatide (PTH 1-34) aloneAnimal study (in vivo)Pharmacokinetics
In sheep, powder nasal PTH had relative bioavailability of 1.0%.
In plain wordsIn sheep, powder nasal PTH had relative bioavailability of 1.0%.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicablePowder nasal relative bioavailability
Study
sheepn: not reported in source
Ovine crossover pharmacokinetic model
Outcome group
Pharmacokinetics · Pharmacology
Measurements
Relative bioavailability
1%
powder nasal formulation
Source sentences
Summary
In this preclinical model, the relative bioavailability of liquid and powder nasal formulations was 1.4% and 1.0% respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Subsequently, we investigated the pharmacokinetics of the liquid nasal spray formulation as well as a dry powder nasal formulation also containing Solutol^® HS15 in a crossover study in an established ovine model.
In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Teriparatide (PTH 1-34).
Show in the study text Report a problemFND-3118166205

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

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