Pharmaceuticals

Dimethyl Sulfoxide (DMSO) is widely used in the pharmaceutical industry for the purposes of drug discovery, API synthesis, and analytical applications. It is also an excipient solvent in pharmaceutical drug delivery systems. Procipient® (Dimethyl Sulfoxide USP, Ph. Eur.) addresses the quality and regulatory requirements, as required by the FDA, for these specific applications. Contact us for assistance in grade selection.

Dimethyl Sulfide (DMS) is primarily used in the synthesis of Active Pharmaceutical Ingredients. In its sulfonium salt form, it acts as a reagent in the synthesis of borane reducing agents (BH3-DMS) and is also utilized in epoxidation and hydroboration-oxidation reactions.

Applications

Drug Delivery

Procipient®(Dimethyl Sulfoxide USP, Ph. Eur.) is used in topical and parenteral drug delivery. Details of DMSO in approved products can be located in the U.S. Food and Drug Administration-Center for Drug Evaluation and Research’s database Inactive Ingredient Search for Approved Drug Products.

Topical Dosages

Procipient®(Dimethyl Sulfoxide USP, Ph. Eur.) has been recognized for many years as a topical penetration enhancer. Both human and animal health applications currently exist which use DMSO in this role.

Solvent properties of DMSO may be beneficial in that higher loading of the API in semisolid products can sometimes be achieved.

The low vapor pressure of DMSO enables formulations to absorb without the skin-chilling effect of excipients such as alcohol.

From a formulation standpoint, DMSO viscosity is similar to water and DMSO can serve as a way to lower formulation viscosity. The addition of traditional thickening agents (Carbopol®, Klucel®, Methocel®, Tylose®) can be a way to increase DMSO viscosity allowing for optimally designed dosage forms.

Parenteral Dosages

Approved applications for this route of administration exist for Procipient® (Dimethyl Sulfoxide USP, PhEur)  where it provides solubility to the API. Worldwide, many innovative applications are currently being evaluated for small volume parenteral products and vaccines.

Emerging applications include autologous cell processing and the delivery (or processing) of carbohydrates using a compendial DMSO product. DMSO may also act as a process aid for biopolymers used in parenteral dosage forms.

Procipient® has been used as an excipient to solubilize the drug product to be delivered as a long acting injectable and to dissolve medical polymers like EVOH, PLA, PLGA and other biomaterials that precipitate in situ to form biodegradable implants.

As an API

Procipient® is approved throughout the world as an API (Active Pharmaceutical Ingredient) for the treatment of Interstitial Cystitis. The approved formulation is a sterile 50% aqueous DMSO solution that is instilled into the bladder.

While this is the only approved indication for DMSO in North America DMSO, it is used on other parts of the world as a topical anti-inflammatory in addition to traditional self-medication applications.

Cryopreservation

3d rendering of cells , virus or genetic molecule

DMSO is well known in Cryopreservation. Procipient® is an ingredient in cryo-media for the cryopreservation of cells and biological tissue for various end use applications.

DMSO passes through cell membranes more readily than glycerol.

When combined with water, DMSO exhibits unique and interesting thermodynamic properties. The eutectic mixture of the combination results in a liquid at minus 80°C DMSO/Water, preventing damaging the cells from ice formation and disrupting cellular structure while maintaining viability of the cells.

Analytical

Various instrumental methods require consistent solvents with well characterized impurity profiles.

DMSO can be used in analytical applications and excels due to the wide range of materials DMSO will dissolve.

DMSO is useful for:

  • The analysis of polymers, inorganic and organic compounds by UV and IR spectroscopy.
  • As a solvent in the preparation of samples for HPLC analysis and is an ‘universal solvent’ for poorly soluble drugs.

We manufacture two grades of DMSO conforming to ACS (American Chemical Society’s) Monographs.

DMSO ACS Reagent Grade and the more optically pure DMSO ACS Spectrophotometric Grade.

HTS / Compound Storage

DMSO exhibits outstanding solvent capability for both organic and inorganic compounds.

These characteristics make DMSO a widely used solvent in compound discovery laboratories for compound library storage. DMSO is also used in analytical or High Throughput Screening processes.

Typically DMSO ACS Spectrophotometric Grade is selected for library storage.

The clean impurity profile of DMSO ACS Spectrophotometric Grade insures the DMSO will remain a consistent background that doesn’t contribute interferences.

Synthesis

DMSO has been an essential part of numerous pharmaceutical syntheses that are currently in various clinical trial stages or commercial phases.

Azoles, Quinolone antibiotics and macrolides are some specific pharmacological drug classes which benefit from the use of DMSO.

As a reagent, DMSO is key to a class of mild and selectivity oxidation reactions. DMSO can be used to form the dimsyl ion, which is a strong base useful in alkylation, nucleophilic displacement and condensation reactions.

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