Dry powder vancomycin compositions and associated methods

A vancomycin and composition technology, applied in the field of dry powder, can solve the problems of patient burden, inappropriate dose, no vancomycin dry powder, etc.

Inactive Publication Date: 2014-04-09
SAVARA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, off-label use of approved drugs may put patients at risk because their safety and efficacy have not been studied and/or may provide inappropriate dosages
Additionally, drug del

Method used

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  • Dry powder vancomycin compositions and associated methods
  • Dry powder vancomycin compositions and associated methods
  • Dry powder vancomycin compositions and associated methods

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Dry powder vancomycin compositions were manufactured in high yields (75-95%) and in two different batch sizes (1 g and 20 g) without loss of purity using a Buchi laboratory scale spray dryer. These powders showed very high delivery efficiency and lot-to-lot consistency.

[0055] The full aerodynamic particle size distribution of the 20g batch is shown in figure 1 , the figure shows that the vast majority of the particle size distribution is smaller than 5 μm and that a large proportion (about 59%) is within the ultrafine particle fraction (3 μm) predicted for deep lung delivery.

[0056] Preliminary studies have shown that the delivered dose content uniformity of vancomycin powder readily meets the technical requirements of FDA's draft guidance on aerosol dose uniformity. In the last 10 years, this has become one of the biggest challenges facing the pulmonary drug delivery industry. The technical requirements state that no more than one out of 10 times should be outs...

Embodiment 2

[0074] As mentioned above, in some embodiments, the dry powder vancomycin composition of the present invention can be prepared by spray drying. This method has proven to be very efficient and shows excellent batch-to-batch consistency.

[0075] Table 3 below shows primary particle size and moisture content data for batch sizes ranging from 25 g to 100 g, which were prepared by spray drying. x 10 、X 50 and x 90 are the mass diameters of the particles below which 10%, 50% and 90% of the distribution falls, respectively. ND = not determined.

[0076] Also, for lot number G-11-26-1, Figure 6 The complete aerodynamic particle size distribution is shown in and shows that the vast majority of the particle size distribution is smaller than 5 μm (85%) and a large fraction (about 70%) is in the ultrafine particle fraction (<3 μm) expected for deep lung delivery. )Inside.

[0077] table 3

[0078]

[0079]

[0080] Figure 7 Shows that the delivered dose content uniformit...

Embodiment 3

[0086] Vancomycin-leucine formulations contain carbohydrate bulking agents. The formulation was subjected to a chemical stability study at 50°C for 4 weeks. Figure 8 It is shown that the addition of a carbohydrate bulking agent (eg, trehalose) can improve the chemical stability of the dry powder vancomycin composition of the present invention.

[0087] Two lots of vancomycin compositions containing 10% leucine were compared. One of the batches contained no process modifications (Lot SA010) and the other was processed under a nitrogen atmosphere and protected from light and moisture (Lot G-11-026-1). Such as Figure 9 As shown in , these modifications significantly delayed the degradation of vancomycin. Indeed, extrapolation of these data indicates that the composition is stable at room temperature for at least 2 years.

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Abstract

Dry powder vancomycin compositions and methods for administering and preparing such compositions. A composition of the present disclosure may be administered to a subject via pulmonary administration in an amount effective to treat and/or prevent a bacterial infection in the subject. Administration of an effective amount of a composition of the present disclosure may be particularly useful in treating a gram-positive bacterial infection in a subject suffering from pneumonia, cystic fibrosis, bronchiectasis, or other chronic lung disease with a bacterial infection of the subject's airway and/or lung.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to US Patent Application Serial No. 61 / 487,971, filed May 19, 2011, the contents of which are incorporated herein by reference. Background technique [0003] Vancomycin is a glycopeptide antibiotic used in the prevention and treatment of infections caused by Gram-positive bacteria. Vancomycin is the International Nonproprietary Name (INN) corresponding to the compound having the formula: [0004] [0005] It has been suggested that vancomycin acts by inhibiting cell wall synthesis in Gram-positive bacteria. More specifically, vancomycin is thought to prevent the incorporation of N-acetylmuramic acid (NAM) and N-acetylglucosamine (NAG) glycan subunits into the peptidoglycan matrix; the peptidoglycan matrix forms Gram-positive bacteria The main structural component of the cell wall. Binding of vancomycin to the terminal D-alanyl-D-alanine moieties of NAM and NAG-peptides prevents the...

Claims

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Application Information

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IPC IPC(8): A61K38/14
CPCA61K38/14A61K31/198A61K9/0075A61K9/1617A61P11/00A61P31/00A61P31/04A61K2300/00A61K9/4808A61K2121/00
Inventor J·洛德J·T·乔希凯宁H·E·斯奈德P·索尼M-C·郭
Owner SAVARA
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