Minerals as Excipients – Dr. Paul Lohmann

The major component of ingredients in pharmaceutical products in terms of volume is not the active ingredient itself, it is the excipient. Excipients assist in the administration of an ‘active’ substance that typically may not be easily administered or absorbed by the patient.

Mineral Salts as excipients are of specific importance, since they largely determine the structure of solid dosage forms and stabilize the chemical properties in liquid pharmaceutical forms.

Excipients have well-defined functions, which significantly influence the processability, stability and control the release of the drug product. Therefore, the selection of excipients is crucial to ensure that the drug substance is stable and has
desired pharmacokinetic properties, adhering to strict standards and regulations.

Produced for Functionality

Excipients fall into several broad processing categories for functionalities. 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.

A pH-adjuster modifies the pH-value in order to stabilize the drug substance in parenteral dosage forms or optimize the taste and disintegration in oral effervescent tablets. A whitening agent/white color pigment is often used to obtain white tablets. Due to the chemical nature of Mineral Salts, Dr. Paul Lohmann® products are often 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.

Minerals as Excipients

The following reference tables are based on USP 43 – NF 381. The grouping of excipients by functional category is intended to summarize commonly identified purposes that these Mineral Salts as excipients serve in drug product formulations.

Antioxidant

Antioxidant
Antioxidant

Coating Agent

Coating Agent
Coating Agent

Emollient

Emollient
Emollient

Wet Binder

Wet Binder
Wet Binder

These are just 4 of 13 salts themes.

Tailor-made Solutions for state-of-theart Applications

There is an ongoing trend in the industry to reduce process complexity. Therefore, we offer product lines which address this actual trend.

Product line Low in Endotoxins

Dr. Paul Lohmann® offers excipients even in Low in Endotoxins pharmaceutical grades which are applied in parenteral preparations such as infusions or injections. These highly sensitive routes of administration require highest purity standards, which are fulfilled by our Quality by Design (QbD) approach. A dedicated purpose built GMP certified plant ensures the production of excipients meeting highest purity. Biopharmaceuticals, vaccines and blood plasma derived medicines utilize Phosphates and Citrates as excipients to achieve the required pH-value or EDTAs to stabilize the drug substance. Dr. Paul Lohmann® Low in Endotoxin Mineral Salt excipients enable a seamless integration into the production process and reduce process complexity.

Product Modification

Modification of chemical properties
◆ Solubility
◆ pH-value
◆ Concentration
◆ Assay
◆ Color
◆ Water content
◆ Flowability
◆ Purity

Particle size engineering Granules
◆ Excellent flowability
◆ Reduced dust
◆ Minimized material agglomeration

Granules for Direct Compression
◆ Optimum tablet compression characteristics
◆ Improved dosage
◆ Only small amounts of binders necessary

Micronization
◆ Improved dispersion behavior in a liquid or semi-solid matrix, resulting in improved homogeneity
◆ Reduced sedimentation
◆ Improved mouthfeel
◆ Modification of particle size distribution

Bulk density variation
◆ Optimized ratio between weight and volume
◆ Ultralight to heavy qualities available Solutions
◆ Energy and resource efficient
◆ Organic solvent-free – water based
◆ Easier processing

 

See the full brochure onMinerals as Excipientshere

(click the picture to download the brochure)

Brochure_Excipients_DPL

Source: Dr. Paul Lohmann brochure “Minerals as Excipients”


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