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مشتقات اسید آمینه
مشتقات لاکتات
Excipients for sustained drug
Excipients for solubility and
Gattefoss & solubilizers
Excipients for taste masking
مشتقات اسید آمینه
| Carnipure™ crystalline | Carnipure™ tartrate |
| 100% pure L-Carnitine | Stable salt containing approximately 68% L-Carnitine, 32% natural L-tartaric acid |
| White, crystalline powder | White, crystalline powder |
| Highly water soluble, forms colorless solutions | Highly water soluble, forms colorless solutions |
| Odorless | Odorless, pleasant fruity flavor |
| Heat stable up to 120°C | Heat stable up to 120°C |
| Hygroscopic – especially suitable for liquid applications | Non-hygroscopic – suitable for all solid and liquid applications |
| Generally Recognized As Safe (GRAS) | Generally Recognized As Safe (GRAS) |
| Excellent safety profile – LD50 could not be determined | Excellent safety profile – LD50 could not be determined |
| Meets specifications of Food Chemicals Codex (F.C.C.) and United States Pharmacopoeia (U.S.P.) |
L-Carnitine and L-Tartaric acid used to produce L- Carnitine L-Tartrate meet specifications of F.C.C. and U.S.P. |
| U.S. patent 5,073,376 and other international patents | |
| Kosher, OU certified | Kosher, OU certified |
| Free of animal products | Free of animal products |
| Free of genetically modified organisms (GMOs) | Free of genetically modified organisms (GMOs) |
مشتقات لاکتات
| Product name | Pharmacopoeia | Specification |
| PURAC® PF | USP, JP, EP | L (+) Lactic Acid pharma grade |
| PURASAL® S/PF 50% | USP, EP, JPC | sodium–S–lactate pharma grade 50% |
| PURASAL® S/PF 60% | USP, EP, JPC | sodium–S–lactate pharma grade 60% |
| PURACAL® PP/USP | USP, EP | calcium lactate pharma grade |
| PURACAL® DC | USP, EP | calcium lactate for direct compressible use |
| PURACAL® XPRESS | calcium lactate gluconate pharma grade | |
| GLUCONAL® CAM-P-IN-EP | EP | calcium gluconate monohydrate pharma grade for injectable applications |
| GLUCONAL® CAM-P-IN | USP | calcium gluconate monohydrate pharma grade for injectable applications |
| GLUCONAL® CAM-P-OR | USP, EP | calcium gluconate monohydrate pharma grade for oral applications |
| GLUCONAL® CADS | USP | calcium D-saccharate |
| GLUCONAL® FE-Pharma | USP, EP | ferrous gluconate pharma grade |
| GLUCONAL® MG | USP | magnesium gluconate |
| GLUCONAL® K | USP | potassium gluconate |
| GLUCONAL® ZN | USP | zinc gluconate |
| PURAMEX® MG | EP | magnesium lactate |
| PURAMEX® ZN | zinc lactate |
Excipients for sustained drug
| Products | Chemical description | Form | HLB | Melting point (°C) (capillary tube) |
Drop point (°C) (Mettler) | Techniques |
| Precirol® ATO 5 | Glycerol distearate (type I) EP Glyceryl distearate NF |
Powder* | 2 | 50.0-60.0 | 53.0-57.0 | Extrusion (melt/partial melt) Melt coating Spray cooling/prilling Capsule molding |
| Geleol™ Mono and Diglycerides NF |
Glycerol monostearate 40-55 (type I) EP Mono and diglycerides NF |
Pellets | 3 | 54.0-64.0 | 54.5-64.5 | Extrusion (melt/partial melt) Melt coating Capsule molding |
Excipients for solubility and
| Excipients for solubility and bioavailability enhancement | ||||
| Products | Chemical description | HLB | Functionality | |
| Gelucire® 48/16 | Macrogol stearate (type I) EP Polyoxyl stearate (type I) NF |
12 | Water soluble surfactant | |
| Labrasol® ALF | Caprylocaproyl macrogol-8 glycerides EP Caprylocaproyl polyoxyl-8 glycerides NF |
12 | Water dispersible surfactant | |
| Gelucire® 44/14 | Lauroyl macrogol-32 glycerides EP Lauroyl polyoxyl-32 glycerides NF |
11 | ||
| Gelucire® 50/13 | Stearoyl macrogol-32 glycerides EP Stearoyl polyoxyl-32 glycerides NF |
11 | ||
| Labrafil® M 1944 CS | Oleoyl macrogol-6 glycerides EP Oleoyl polyoxyl-6 glycerides NF |
9 | ||
| Labrafil® M 2125 CS | Linoleoyl macrogol-6 glycerides EP Linoleoyl polyoxyl-6 glycerides NF |
9 | ||
| Labrafil® M 2130 CS | Lauroyl macrogol-6 glycerides EP Lauroyl polyoxyl-6 glycerides NF |
9 | ||
| Capryol® PGMC | Propylene glycol monocaprylate (type I) NF |
6 | Water insoluble surfactant | |
| Capryol® 90 | Propylene glycol monocaprylate (type II) NF |
5 | ||
| Lauroglycol™ FCC | Propylene glycol monolaurate (type I) EP/NF |
5 | ||
| Lauroglycol™ 90 | Propylene glycol monolaurate (type II) EP/NF |
3 | ||
| Plurol® Oleique CC 497 | Polyglyceryl-3 dioleate NF | 3 | ||
| Maisine® CC | Glycerol monolinoleate EP Glyceryl monolinoleate NF |
1 | Oily vehicle | |
| Peceol™ | Glycerol monooleate (type 40) EP Glyceryl monooleate (type 40) NF |
1 | ||
| Labrafac™ PG | Propylene glycol dicaprylocaprate EP Propylene glycol dicaprylate/dicaprate NF |
1 | ||
| Labrafac™ Lipophile WL 1349 | Triglycerides medium-chain EP Medium chain triglycerides NF Medium chain fatty acid triglyceride JPE |
1 | ||
| Transcutol® HP | Highly purified diethylene glycol monoethyl ether EP/NF |
/ | Co-solvent | |
Gattefoss & solubilizers
| (Gattefossé solubilizers and Lipid-based Formulation Classification System (LFCS | ||||
| Products | Functionality | LFCS | Solubility in water | HLB |
| Gelucire® 48/16 | Water soluble surfactant | Type IV, micellar | Transparent micellar solution | 12 |
| Gelucire® 44/14 Labrasol® ALF |
Water dispersible surfactant | Type III fine emulsion/ microemulsion | Translucent dispersion | 10-12 |
| Labrafil® (s) | Wetting agent | Type II formulation Coarse emulsion | Milky dispersion | 7-9 |
| Capryol® (s) Lauroglycol™ FCC | Water insoluble surfactant | Use in Type II/III | Dispersion | 5-6 |
| Lauroglycol™ 90 Plurol® Oleique CC 497 |
Water insoluble surfactant | Use in Type II/III | Insoluble | 2-4 |
| Maisine® CC Peceol™ | Oily phase | Use in Type I | Insoluble | 1 |
Excipients for taste masking
| Excipients for taste masking and API protection | ||||||
| Products |
Chemical description | Form | HLB | Melting point (°C) (capillary tube) |
Drop point (°C) (Mettler) |
Techniques |
| Taste Masking | ||||||
| Precirol® ATO 5 | Glycerol distearate (type I) EP Glyceryl distearate NF |
Powder* | 2 | 50.0-60.0 | 53.0-57.0 | Hot melt coating Melt granulation Extrusion (melt/partial melt) |
| Geleol™ Mono and Diglycerides NF | Glycerol monostearate 40-55 (type I) EP Mono and diglycerides NF |
Pellets | 3 | 54.0-64.0 | 54.5-64.5 | Melt granulation Extrusion (melt/partial melt) |
| API protection / API compatibility | ||||||
| Gelucire® 43/01 | Hard fat EP/NF/JPE |
Pellets | 1 | / | 42.5-46.0 | Capsule molding |