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.