Mineral Salts as Preservatives

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 process-ability, 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.
  • pH-Adjusters modifies the acidity in order to stabilize the drug substance in parenteral dosage forms or optimize the taste and disintegration in oral effervescent tablets.

According to scientific literature, select mineral salts also have an interesting effect as Preservatives, preventing degradation and helping to achieve sufficient shelf stability.  Mineral salts produced by Dr Paul Lohmann® are not approved for use as active pharmaceutical ingredients or as antimicrobials in the USA.

Product Physical appearance Quality Solubility | 20 °C
Calcium Acetate powder Ph.Eur.; Low in Endotoxins +
Calcium Acetate powder FCC | USP +
Calcium Acetate powder Ph.Eur. | BP | ACS +
Calcium Acetate fine powder USP +
Calcium Acetate fine granules USP | FCC +
Calcium Acetate granules USP | FCC +
Calcium Acetate granules Ph.Eur. | USP | BP +
Calcium Lactate granular powder Ph.Eur. | USP | FCC +
Calcium Lactate granules Ph.Eur. +
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; Low in Endotoxins ++
Sodium Acetate 3-hydrate crystals Ph.Eur. | USP | FCC ++
Sodium Benzoate micronized powder Ph.Eur. | FCC | NF +
Sodium L-Lactate solution; approx. 50% 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 solution
Sodium L-Lactate solution; approx. 60% Ph.Eur. | USP; Low in Endotoxins solution
Sodium L-Lactate solution; approx. 70% Ph.Eur. | USP solution
Sodium Propionate crystals Ph.Eur. | FCC | NF +
Sodium Propionate granules Ph.Eur. | FCC +
Zinc Oxide powder USP

 

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 their business partners and clients, creating new solutions for modern manufacturing.