Solid-State Chemistry of Cromolyn Sodium (Disodium Cromoglycate)

A detailed crystallographic study was made to provide a better understanding and control of processing steps, purity control, and dosage formulations of cromolyn sodium. The compound, an odorless, white, hydrated crystalline powder, is the disodium salt of the dibasic acid: 1,3-bis(2-carboxychromon-...

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Veröffentlicht in:Journal of pharmaceutical sciences 1971-10, Vol.60 (10), p.1458-1465
Hauptverfasser: Cox, J.S.G., Woodard, G.D., McCrone, W.C.
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container_end_page 1465
container_issue 10
container_start_page 1458
container_title Journal of pharmaceutical sciences
container_volume 60
creator Cox, J.S.G.
Woodard, G.D.
McCrone, W.C.
description A detailed crystallographic study was made to provide a better understanding and control of processing steps, purity control, and dosage formulations of cromolyn sodium. The compound, an odorless, white, hydrated crystalline powder, is the disodium salt of the dibasic acid: 1,3-bis(2-carboxychromon-5-yloxy)-2-hydroxypropane. No crystalline polymorphs were observed, but the crystals can quickly absorb (or lose) water as a continuous series of interstitial solid solutions. The amount of water absorbed or lost is proportional to the relative humidity of the environment of the crystals. At 90% R.H., the interstitial water approaches 24 wt. %, or nine molecules per molecule of cromolyn sodium. The absorbed water causes the lattice to expand reversibly, especially in the b crystallographic direction, and this results in remarkable changes in the X-ray diffraction pattern, density, and other physical properties. Above about 93% R.H., the compound absorbs more water than the crystals can hold. They then collapse to form one of two lyotropic mesophases, containing up to about 260 molecules of water per molecule of cromolyn sodium at 20° or about 10 wt. % cromolyn sodium.
doi_str_mv 10.1002/jps.2600601003
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The compound, an odorless, white, hydrated crystalline powder, is the disodium salt of the dibasic acid: 1,3-bis(2-carboxychromon-5-yloxy)-2-hydroxypropane. No crystalline polymorphs were observed, but the crystals can quickly absorb (or lose) water as a continuous series of interstitial solid solutions. The amount of water absorbed or lost is proportional to the relative humidity of the environment of the crystals. At 90% R.H., the interstitial water approaches 24 wt. %, or nine molecules per molecule of cromolyn sodium. The absorbed water causes the lattice to expand reversibly, especially in the b crystallographic direction, and this results in remarkable changes in the X-ray diffraction pattern, density, and other physical properties. Above about 93% R.H., the compound absorbs more water than the crystals can hold. 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Pharm. Sci</addtitle><description>A detailed crystallographic study was made to provide a better understanding and control of processing steps, purity control, and dosage formulations of cromolyn sodium. The compound, an odorless, white, hydrated crystalline powder, is the disodium salt of the dibasic acid: 1,3-bis(2-carboxychromon-5-yloxy)-2-hydroxypropane. No crystalline polymorphs were observed, but the crystals can quickly absorb (or lose) water as a continuous series of interstitial solid solutions. The amount of water absorbed or lost is proportional to the relative humidity of the environment of the crystals. At 90% R.H., the interstitial water approaches 24 wt. %, or nine molecules per molecule of cromolyn sodium. The absorbed water causes the lattice to expand reversibly, especially in the b crystallographic direction, and this results in remarkable changes in the X-ray diffraction pattern, density, and other physical properties. Above about 93% R.H., the compound absorbs more water than the crystals can hold. 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Pharm. Sci</addtitle><date>1971-10</date><risdate>1971</risdate><volume>60</volume><issue>10</issue><spage>1458</spage><epage>1465</epage><pages>1458-1465</pages><issn>0022-3549</issn><eissn>1520-6017</eissn><abstract>A detailed crystallographic study was made to provide a better understanding and control of processing steps, purity control, and dosage formulations of cromolyn sodium. The compound, an odorless, white, hydrated crystalline powder, is the disodium salt of the dibasic acid: 1,3-bis(2-carboxychromon-5-yloxy)-2-hydroxypropane. No crystalline polymorphs were observed, but the crystals can quickly absorb (or lose) water as a continuous series of interstitial solid solutions. The amount of water absorbed or lost is proportional to the relative humidity of the environment of the crystals. At 90% R.H., the interstitial water approaches 24 wt. %, or nine molecules per molecule of cromolyn sodium. The absorbed water causes the lattice to expand reversibly, especially in the b crystallographic direction, and this results in remarkable changes in the X-ray diffraction pattern, density, and other physical properties. Above about 93% R.H., the compound absorbs more water than the crystals can hold. They then collapse to form one of two lyotropic mesophases, containing up to about 260 molecules of water per molecule of cromolyn sodium at 20° or about 10 wt. % cromolyn sodium.</abstract><cop>Washington</cop><pub>Elsevier Inc</pub><pmid>5001963</pmid><doi>10.1002/jps.2600601003</doi><tpages>8</tpages></addata></record>
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source MEDLINE; Access via Wiley Online Library; Alma/SFX Local Collection
subjects Aerosol dry powder-cromolyn sodium
Aerosol dry powder—cromolyn sodium, crystallography
Aerosols
Chromones - analysis
Cromolyn Sodium - analysis
Cromolyn sodium-crystallography
Crystallography
Crystallography—cromolyn sodium (disodium cromoglycate)
Disodium cromoglycate-crystallography
Models, Theoretical
Solubility
Temperature
Water - analysis
X-Ray Diffraction
title Solid-State Chemistry of Cromolyn Sodium (Disodium Cromoglycate)
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