Pharma
Mineral Salts for Regulating pH
The major ingredient in pharmaceutical formulations is often not the active itself, it’s the excipients. Excipients assist in the delivery of an ‘active’ that might otherwise be difficult to administer.
Mineral Salts as excipients are of specific importance because they largely determine the structure of solid dosage forms and stabilize the chemical properties in liquid pharmaceuticals. Excipients have well-defined functions which significantly influence the processability, stability and controlled delivery and release of the active.
Produced for Functionality
Excipients fall into several broad categories:
- Bulking Agents make the dosage form larger in size so that it becomes easier to manufacture and for patients to handle.
- Binders, which are also used in our granules for direct compression (DC), are utilized to facilitate the granulation process to make powders easier to compress.
- Glidants help the powders flow finally from the hopper to the capsule or tablet cavity and minimize friction and cohesion between particles.
- Lubricants are often used in combination with glidants to reduce the stickiness of powders or granules to the dyes or punches during compression.
- Preservatives prevent degradation and help to achieve sufficient shelf stability.
It is well known that specific mineral salts are also effective as pH-Adjusters, modifying the acidity in order to stabilize the drug substance in parenteral dosage forms or optimize the taste and disintegration in oral effervescent tablets. Those mineral salts from Dr. Paul Lohmann® that are especially effective at this are:
| Product | Physical appearance | Quality | Solubility | 20 °C |
|---|---|---|---|
| Calcium Carbonate, heavy | powder | Ph.Eur. | USP | — |
| Calcium Carbonate, heavy | micronized powder | Ph.Eur. | USP | — |
| Tricalcium Phosphate, light | powder | Ph.Eur. | — |
| Tricalcium Phosphate, light | powder | Ph.Eur. | FCC | NF; low in aluminium | — |
| Monopotassium Citrate, anhydrous | powder | E 332(i) | – |
| Tripotassium Citrate, anhydrous | powder | Ph.Eur | + |
| Tripotassium Citrate 1-hydrate | powder | Ph.Eur. | USP | FCC | ++ |
| Tripotassium Citrate 1-hydrate | free flowing powder | E 332(ii); with 0.8 % anti-caking agent | |
| Tripotassium Citrate 1-hydrate | fine crystals | Ph.Eur. | USP | ++ |
| Tripotassium Citrate 1-hydrate | crystals | Ph.Eur. | USP | FCC | JPC | ++ |
| Monopotassium Phosphate | powder | Ph.Eur. | NF | + |
| Dipotassium Phosphate | powder | Ph.Eur. | USP | ++ |
| Dipotassium Phosphate | powder | Ph.Eur.; Low in Endotoxins | ++ |
| Sodium Acetate, anhydrous | powder | USP | FCC | + |
| Sodium Acetate, anhydrous | free-flowing powder | E 262(i); with 0.2 % anti-caking agent | |
| Sodium Acetate, anhydrous | granules | USP | + |
| Sodium Acetate 3-hydrate | crystals | Ph.Eur. | USP | FCC | + |
| Sodium Acetate 3-hydrate | crystals | Ph.Eur. | USP; Low in Endotoxins | ++ |
| Sodium Bicarbonate | powder | complies with the limits of Ph.Eur. | – |
| Sodium Bicarbonate | micronized powder | Ph.Eur. | – |
| Sodium Carbonate, anhydrous | powder | Ph.Eur.; suitable for effervescent tablets | – |
| Sodium Carbonate, anhydrous | fine powder | Ph.Eur. | NF | – |
| Sodium Carbonate, anhydrous | fine granules | Ph.Eur. | FCC | NF | JP | – |
| Sodium Carbonate 1-hydrate | powder | Ph.Eur. | – |
| Sodium Carbonate 1-hydrate | crystalline powder | Ph.Eur. | FCC | NF | – |
| Sodium Carbonate 10-hydrate | crystals | Ph.Eur. | FCC | JP | + |
| Monosodium Citrate, anhydrous | powder | DAC | – |
| Monosodium Citrate, anhydrous | micronized powder | DAC | – |
| Monosodium Citrate, anhydrous | fine powder | DAC | – |
| Monosodium Citrate, anhydrous | crystalline powder | DAC; Low in Endotoxins | – |
| Monosodium Citrate, anhydrous | crystals | DAC | – |
| Disodium Citrate 1.5-hydrate | powder | BP | + |
| Disodium Citrate 1.5-hydrate | fine powder | BP | + |
| Disodium Citrate 1.5-hydrate | crystals | BP | + |
| Trisodium Citrate, anhydrous | fine powder | USP | FCC | + |
| Trisodium Citrate, anhydrous | crystalline powder | FCC | USP | JPE | + |
| Trisodium Citrate, anhydrous | fine granules | USP | + |
| Trisodium Citrate 2-hydrate | fine powder | Ph.Eur. | USP | FCC | + |
| Trisodium Citrate 2-hydrate | fine powder | Ph.Eur. | USP | FCC | + |
| Trisodium Citrate 2-hydrate | crystals | Ph.Eur. | USP | FCC | JP | ACS | + |
| Trisodium Citrate 2-hydrate | crystals | Ph.Eur. | USP; Low in Endotoxins | + |
| Trisodium Citrate 2-hydrate | fine crystals | Ph.Eur. | USP | FCC | + |
| Trisodium Citrate 5.5-hydrate | crystals | USP | Erg.B.6 | + |
| Sodium L-Lactate | solution; approx. 50 % | Ph.Eur. | USP | solution |
| Sodium L-Lactate | solution; approx. 60 % | Ph.Eur. | USP | solution |
| Sodium L-Lactate | solution; approx. 70 % | Ph.Eur. | USP | solution |
| Sodium L-Lactate | solution; approx. 50 % | Ph.Eur.; Low in Endotoxins | solution |
| Sodium L-Lactate | solution; approx. 60 % | Ph.Eur. | USP; Low in Endotoxins | solution |
| Monosodium Phosphate, anhydrous | powder | USP | FCC | BP | + |
Mineral Salts continued:
| Product | Physical appearance | Quality | Solubility | 20 °C |
|---|---|---|---|
| Monosodium Phosphate 2-hydrate | powder | Ph.Eur. | USP | + |
| Monosodium Phosphate 2-hydrate | fine crystals | Ph.Eur.; Low in Endotoxins | + |
| Disodium Phosphate, anhydrous | powder | complies with the limits of Ph.Eur. | – |
| Disodium Phosphate 2-hydrate | fine powder | Ph.Eur. | – |
| Disodium Phosphate 2-hydrate | crystals | Ph.Eur. | USP | – |
| Disodium Phosphate 12-hydrate | crystals | Ph.Eur. | USP | + |
| Disodium Phosphate 12-hydrate | crystals | Ph.Eur.; Low in Endotoxins | + |
| Sodium Succinate 6-hydrate | crystalline powder | NF | ++ |
| Sodium Succinate 6-hydrate | crystalline powder | NF; Low in Endotoxins | ++ |
| Disodium Succinate, anhydrous | powder | NF | ++ |
Due to the chemical nature of Mineral Salts, Dr. Paul Lohmann® products are mostly used for functionalities beyond the above-mentioned examples. Since Dr. Paul Lohmann® Mineral Salts are an integral component of pharmaceutical drugs, its excipients fulfill IPEC (International Pharmaceutical Excipients Council) and ISO 9001 guidelines.
With a flexible, innovative spirit, DPL responds to the changing needs of its business partners and clients, creating new solutions for modern manufacturing.