Monodisperse Silica Microspheres

Scientists are always pushing the limits, and looking for more precise products and equipment to enable the next technology.   In an effort to provide those scientists with the right tools Cospheric LLC has added monodisperse silica microspheres to their broad product line.

Silica particles are now available in distributions of less than 10% CV in the sizes of 1.0 micron, 4 micron and 8 micron.

Silica Microsphere Products now available:

SIO2MS 1.0um  <10% CV

SIO2MS 4.0um <10% CV

SIO2MS 8.0um <10% CV

SIO2MS 4-6um  (2-19um range)

FDA-Approved Microspheres

What makes a microsphere FDA-approved?

In order to tell whether the microsphere can be used in cosmetics, food, or medical devices it is important to look at the raw materials that are incorporated into the microsphere during manufacturing process.  For example, unpigmented or clear polyethylene microspheres supplied by Cospheric in sizes from 10 micron to 1000 micron meet the quality requirements of the US FDA as specified in 21 CFR 172.888 and 21 CFR 178.3720.  Specific grade of polyethylene used in manufacturing of these microspheres is  FDA-approved for food applications in chewing gum base, on cheese and raw fruits and vegetables, and as a defoamer in food.

Color additives are subject to a strict system of approval under U.S. law (FD&C Act), sec. 721; 21 U.S.C. 379e. Color additive violations are a common reason for detaining imported cosmetic products offered for entry into this country. If a product contains a color additive, by law [FD&C Act, Sec. 721; 21 U.S.C. 379e; 21 CFR Parts 70 and 80] you must adhere to requirements for:

• Approval. All color additives used in cosmetics (or any other FDA-regulated product) must be approved by FDA. There must be a regulation specifically addressing a substance’s use as a color additive, specifications, and restrictions.
• Certification. In addition to approval, a number of color additives must be batch certified by FDA if they are to be used in cosmetics (or any other FDA-regulated product) marketed in the U.S.
• Identity and specifications. All color additives must meet the requirements for identity and specifications stated in the Code of Federal Regulations (CFR).
• Use and restrictions. Color additives may be used only for the intended uses stated in the regulations that pertain to them. The regulations also specify other restrictions for certain colors, such as the maximum permissible concentration in the finished product.

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Cosmetic Applications of Injectable Polymer Microspheres

Polymer microspheres, in particular injectable polymer particles with a diameter in the range of 30−300 μm, are becoming widely used as a biomaterial in different clinical fields, such as cosmetic surgery, reconstructive surgery, and urology.  Injectable skin fillers offer many benefits in cosmetic dermatology, allowing new forms of facial rejuvenation and wrinkle treatment without surgery. Injectable skin and wrinkle fillers are used to increase tissue volume, reduce wrinkles, and improve skin’s overall contour.

According to The American Society for Aesthetic Plastic Surgery,  two formulations of fillers that are based on microsphere technology are FDA approved for use, differing in design and expected longevity of results.  These injectable microspheres products are used for volume replacement and for deep facial wrinkles (such as the nasolabial folds.) They are not approved for use in the lips.

One of cosmetic dermatology products using injectable microspheres is ArteFill® – a new breed of dermal filler that offers longer lasting results than other cosmetic filler injections. ArteFill® (known as Artecoll® outside of the United States) is made of polymethylmethacrylate (PMMA) microspheres (miniature beads) that are suspended in bovine collagen. Tiny microspheres are made of non-resorbable polymethylmethacrylate – a biocompatable compound that has been used for years.  PMMA has been used since the early 1930s in such common procedures as dental prostheses, eye lenses, bone repair, orthopedics and in pacemakers.  PMMA microspheres are well tolerated by human tissue (no rejection). Continue reading “Cosmetic Applications of Injectable Polymer Microspheres” »