Disclosed herein are heat-stable dry powders which include peptides or protein such as oxytocin for use as a pharmaceutical composition. The composition is highly stable at increased temperatures and relatively high humid environments, and are intended for storage at room temperature with an improved shelf-life. In particular, the dry powders are intended for inhalation, however, other routes of administration can be used when reconstituted in solution.

Disclosed herein are heat-stable dry powders which include peptides or protein such as oxytocin for use as a pharmaceutical composition. The composition is highly stable at increased temperatures and relatively high humid environments, and are intended for storage at room temperature with an improved shelf-life. In particular, the dry powders are intended for inhalation, however, other routes of administration can be used when reconstituted in solution.

Disclosed herein are heat-stable dry powders which include peptides or protein such as oxytocin for use as a pharmaceutical composition. The composition is highly stable at increased temperatures and relatively high humid environments, and are intended for storage at room temperature with an improved shelf-life. In particular, the dry powders are intended for inhalation, however, other routes of administration can be used when reconstituted in solution.

The invention provides novel compositions of bioactive polypeptides and proteins with improved stability and shelf-life. The compositions are based on liquid vehicles selected from semifluorinated alkanes. These vehicles are remarkably effective in protecting polypeptides and proteins from degradation and/or aggregation. The compositions are useful for topical administration, e.g. into an eye, or by parenteral injection, e.g. via the subcutaneous or intramuscular route.

The invention provides novel compositions of bioactive polypeptides and proteins with improved stability and shelf-life. The compositions are based on liquid vehicles selected from semifluorinated alkanes. These vehicles are remarkably effective in protecting polypeptides and proteins from degradation and/or aggregation. The compositions are useful for topical administration, e.g. into an eye, or by parenteral injection, e.g. via the subcutaneous or intramuscular route.

CSF diagnostic in vitro method for the diagnosis of dementias and neuroinflammatory diseases, in which a determination of the procalcitonin immunoreactivity (PCT immunoreactivity) is carried out in a sample of cerebrospinal fluid (CSF) of a patient who is suffering from a dementia or neuroinflammatory disease or is suspected of suffering from such a disease. Conclusions about the presence, the course, the severity or the success of a treatment of the dementia or neuroinflammatory disease are drawn from a measured PCT immunoreactivity which is above a threshold value typical for healthy individuals.

Methods for preparing micro-particles using a double emulsion technique combining a membrane and a micro-sieve are provided. Particularly the present invention relates to method for preparing micro-particles comprising: preparing a first phase comprising an active agent; preparing a second phase comprising a carrier and a solvent; passing the first phase and the second phase through a membrane to form a primary emulsion; passing the primary emulsion through a micro-sieve in a continuous phase to form a secondary emulsion; and removing the solvent to form the micro-particles.

Methods for preparing micro-particles using a double emulsion technique combining a membrane and a micro-sieve are provided. Particularly the present invention relates to method for preparing micro-particles comprising: preparing a first phase comprising an active agent; preparing a second phase comprising a carrier and a solvent; passing the first phase and the second phase through a membrane to form a primary emulsion; passing the primary emulsion through a micro-sieve in a continuous phase to form a secondary emulsion; and removing the solvent to form the micro-particles.

The invention provides a bio-related substance bonded to a high-molecular-weight polyethylene glycol derivative that does not cause vacuolation of cells. The bio-related substance bonded to a degradable polyethylene glycol derivative is represented by the formula (A):

wherein m is 1-7, n1 and n2 are each independently 45-682, p is 1-4, R is an alkyl group having 1-4 carbon atoms, Z is an oligopeptide with 2-8 residues composed of neutral amino acids excluding cysteine, Q is a residue of a compound having 2-5 active hydrogens, D is the bio-related substance, L1, L2, L3, L4 and L5 are each independently a single bond or a divalent spacer, and y is 1-40.

The invention provides a bio-related substance bonded to a high-molecular-weight polyethylene glycol derivative that does not cause vacuolation of cells. The bio-related substance bonded to a degradable polyethylene glycol derivative is represented by the formula (A):

wherein m is 1-7, n1 and n2 are each independently 45-682, p is 1-4, R is an alkyl group having 1-4 carbon atoms, Z is an oligopeptide with 2-8 residues composed of neutral amino acids excluding cysteine, Q is a residue of a compound having 2-5 active hydrogens, D is the bio-related substance, L1, L2, L3, L4 and L5 are each independently a single bond or a divalent spacer, and y is 1-40.