Sepiolite for Pharma & Cosmetics
GRAS-Listed Mineral for Healthcare & Beauty
Sepiolite holds GRAS (Generally Recognized As Safe) status and is used across the pharmaceutical and cosmetic industries as an excipient, thickener, active ingredient carrier, and functional filler. Its biocompatibility, high surface area, and natural origin make it ideal for health-conscious formulations — from controlled-release tablets to luxury facial masks to natural deodorants.
Why Sepiolite for Pharma & Cosmetics
Tablet Excipient
Sepiolite serves as a disintegrant, filler, and flow agent in pharmaceutical tablets. Its high porosity enables rapid water uptake and tablet break-up, while its excellent flow properties improve die filling in high-speed tablet presses.
Controlled Drug Release
The channel structure of sepiolite can be loaded with active pharmaceutical ingredients and programmed for slow, sustained release over 6–24 hours. This reduces dosing frequency and improves patient compliance for chronic medications.
Cosmetic Thickener & Stabiliser
In creams, lotions, and emulsions, sepiolite provides shear-thinning rheology that feels luxurious during application. It stabilises oil-in-water and water-in-oil emulsions without synthetic polymers, supporting 'clean beauty' positioning.
Facial Mask Active
Sepiolite's natural adsorption properties make it a star ingredient in facial masks. It draws out excess sebum, unclogs pores, and delivers minerals to the skin. Its fine, silky texture provides a premium sensory experience.
Natural Deodorant Base
Sepiolite's odour-adsorbing properties extend to personal care. As a base for natural deodorants, it absorbs moisture and neutralises body odour without aluminium salts or synthetic fragrances.
Mycotoxin & Toxin Binding
In veterinary and human gastro-intestinal applications, sepiolite binds aflatoxins, ochratoxins, and bacterial endotoxins in the gut, preventing absorption. This detoxification capability is used in both animal feed supplements and human digestive health products.
From Mine to Your Application
Pharma-Grade Selection
Only the purest sepiolite seams are selected for pharmaceutical and cosmetic applications. Material must meet strict limits for heavy metals, microbiological contamination, and particle size.
Micronisation
The mineral is jet-milled to sub-10 micron particle size for optimal incorporation into tablets, creams, and powders. Fine control of particle size distribution ensures batch consistency.
Sterilisation & Testing
Pharma-grade batches undergo dry-heat sterilisation and are tested to pharmacopeial standards for total aerobic count, yeasts/moulds, E. coli, Salmonella, and Staphylococcus.
Stability Studies
We conduct accelerated and long-term stability studies on finished formulations to validate that sepiolite does not affect product stability, activity, or appearance over its shelf life.
Regulatory Documentation
We provide full regulatory support including Certificates of Analysis, DMF (Drug Master File) access, MSDS, and technical dossiers for registration in EU, US, and other markets.
Typical Specifications
| Parameter | Value |
|---|---|
| Purity | ≥ 95% sepiolite (pharma grade) |
| Particle Size (D50) | 3–7 µm |
| Heavy Metals (total) | < 20 ppm |
| Microbiological | Meets Ph. Eur. / USP limits |
| Moisture | < 10% |
| pH (10% slurry) | 7.5–8.5 |
| Packaging | 10kg sealed drums / 25kg bags |
Frequently Asked Questions
Sepiolite has GRAS status in the US and is listed as a food additive (E560b) in the EU. It has a long history of safe oral use in antacid tablets, animal feed, and gastro-intestinal detoxification products. Toxicological studies confirm no adverse effects at recommended dosages.
Absolutely. Sepiolite is 100% natural, minimally processed, free of synthetic chemicals, and compliant with most clean beauty standards (COSMOS Natural, EWG Verified, etc.). It is an ideal ingredient for brands positioning themselves in the natural and organic beauty segment.
We provide Certificates of Analysis (CoA) per batch, Material Safety Data Sheets (MSDS), technical data sheets, stability data, microbiological test reports, and can grant access to our Drug Master File (DMF) for pharmaceutical customers.
Yes. Sepiolite's mild abrasiveness and adsorption properties make it suitable for natural toothpaste formulations. It provides gentle cleaning, helps remove stains, and can carry fluoride or other active ingredients for controlled release during brushing.
Minimum order for pharma-grade sepiolite is 500kg. Sample quantities of 1–5kg are available for formulation development and testing. Lead time for pharma-grade production is 4–6 weeks from order confirmation.
Ready to Explore Sepiolite for Your Application?
Our technical team provides samples, specifications, and formulation guidance tailored to your industry needs.
