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Methods for stably incorporating substances within dry, foamed glass matrices and compositions obtained thereby

a technology of foamed glass and compositions, applied in the direction of pharmaceutical delivery mechanisms, pill delivery, heterocyclic compound active ingredients, etc., can solve the problems of large loss, loss of whole batches at production level, and many freeze-dried substances are still unstable at ambient temperatures

Inactive Publication Date: 2005-08-25
QUADRANT DRUG DELIVERY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0011] Another aspect of the invention encompasses methods for producing stable, dried, readily soluble single dosages of a substance which is unstable in solution. These methods include preparing a mixture comprising at least one glass matrix-form

Problems solved by technology

This drying method, conventionally used in the absence of effective alternatives, often results in significant losses.
Furthermore, many of the various parameters within the freeze-drying process remain poorly characterized, sometimes resulting in the loss of whole batches at the production level.
In spite of the apparent ubiquity of freeze-drying, many freeze-dried substances are still unstable at ambient temperatures.
Damage caused by this process may be circumvented, to a certain degree, by the use of cryoprotectants.
This imposes inherent instability upon storage of the freeze-dried substances.
However, ambient temperature drying often yields denatured or even inactive substances unless an appropriate stabilizer is used.
Crystallisation or co-precipitation can only be applied to a few substances, and the products of these methods have poor solubility.
Additionally, there are problems in removing residual moisture.

Method used

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  • Methods for stably incorporating substances within dry, foamed glass matrices and compositions obtained thereby
  • Methods for stably incorporating substances within dry, foamed glass matrices and compositions obtained thereby
  • Methods for stably incorporating substances within dry, foamed glass matrices and compositions obtained thereby

Examples

Experimental program
Comparison scheme
Effect test

example 1

Effect of Vacuum Pressure and External Temperature on Primary Drying Times

[0066] 2 ml aliquots of 10% (w / v) trehalose in deionized distilled water were placed in 10 ml Wheaton pharmaceutical vials and dried in an FTS drier at various vacuum pressures and shelf temperature settings. The sample temperatures and the time taken to remove approximately 90% of the water (i.e. primary drying to give a syrup) were determined. The results are shown in Table 1.

example 2

Formation of FGMs

2a. Formation from an Aqueous Solution of Glass Matrix-Forming Material

[0067] Aliquots of 250, 410 μl and 500 μl of a 50% (w / v) solution of trehalose in 3 ml, 5 ml and 10 ml pharmaceutical vials respectively, were dried in an FTS drier for 16 hrs. The shelf temperature was maintained at 25° C. throughout the run and the vacuum pressure dropped to 0.03 Torr / mm Hg within the first 15 mins of the run and maintained at 0.03 Torr / mm Hg throughout the run. The FGMs formed are shown in FIG. 1A. The foam-like appearance is due to the instantaneous drying of the bubbles that form during the boiling step.

2b. Formation From an Aqueous Solution of Glass Matrix-Forming Materials Incorporating Active in Solution

[0068] Recombinant Hepatitis B Surface Antigen in 20% (w / v) trehalose±0.5% (w / v) Byco A in PBS was dried in 300 μl volumes in 3 ml pharmaceutical vials. The FTS drying protocol involved a pressure of 0.03 Torr / mm Hg with shelf temperature maintained at 40° C. throughou...

example 3

Effect of Vacuum Pressure / Shelf Temperature on FGM Formation

3a. Formation From Solution of Glass Matrix-Forming Material Plus Additive

[0078] Aliquots of 1 ml or 500 μl of 25% (w / v) trehalose containing either 0.25 or 0.5 M ammonium bicarbonate, were dried in 10 ml pharmaceutical vials in the FTS drier. The 1 ml samples were dried at a constant vacuum pressure of 0.03 Torr / mm Hg for 14 hrs, with shelf temperature initially 25° C., raised to 45° C. after the first 2 hours (i.e., syrup formed). The 500 μl samples were dried at a constant shelf temperature of 25° C. and a constant vacuum-pressure of 0.01 Torr / mm Hg for 14 hr. The FGMs formed (FIG. 2A) occupied larger volumes than identical samples processed by freeze-drying (FIG. 2B).

3b. Formation From Solution of Glass Matrix-Forming Material Incorporating an Active

[0079] 300 μl aliquots of a solution of 43.4 mg / ml trehalose containing 66 mg / ml of an antimicrobial peptide was dried in 10 ml polypropylene tubes (10 mm diameter) in t...

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Abstract

The invention provides methods for producing foamed glass and the compositions obtained thereby. The compositions are suitable for stable storage of a wide variety of substances, particularly biological and pharmaceutical.

Description

TECHNICAL FIELD [0001] This invention relates to methods of making foamed glasses and compositions obtained thereby. More specifically, it relates to methods of stably incorporating substances, particularly biological substances, into dried foamed glass matrices (FGMs) and the compositions obtained thereby. BACKGROUND OF THE INVENTION [0002] Traditionally, the most common method of preserving biological substances which are unstable in solution at ambient temperatures, such as proteins and DNA, has been freeze-drying. This process involves placing the substance in solution, freezing the solution, and exposing the frozen solid to a vacuum under conditions where it remains solid and the water and any other volatile components are removed by sublimation. The resulting dried formulation contains the biological substance and any salts or other non-volatile materials added to the solution before drying. This drying method, conventionally used in the absence of effective alternatives, ofte...

Claims

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Application Information

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IPC IPC(8): A61K9/20C12N1/04
CPCA61K9/2018C12N1/04A61K9/2095Y02A50/30
Inventor ROSER, BRUCEGRIBBON, ENDA MARTIN
Owner QUADRANT DRUG DELIVERY
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