Docusate Uses in the Pharmaceutical Industry
Docusate is used in the pharmaceutical industry both as an active pharmaceutical ingredient at high concentrations (typically 100 mg to 250 mg) for laxative products, and as an excipient where it provides exceptional wetting properties to formulate hydrophobic active ingredients.
As a laxative, Docusate is extremely gentle. Unlike irritant and stimulant laxatives, Docusate is a stool softener laxative without side effects of cramping. It will increase the amount of moisture to stools, making them softer and easier to pass, and will provide a comfortable bowel movement.
As an excipient, it is the best wetting agent in the pharmaceutical industry. It allows in particular to wet very hydrophobic active ingredients, stabilize micro or nano dispersions and disperse formulations in wet granulation and direct compression.
Docusate product forms
Docusate is available from Solvay with different counter ions (Sodium, Calcium, Potasssium) and different physical forms (pure waxy material, free flowing powder or liquid). These products are all manufactured under cGMP conditions, with USP/EP monographs compliance, US DMF filed and EU CEP Certificate of suitability approved. Solvay provides a strong quality and regulatory support to ease drug approval processes.
Docusate: The best wetting agent in the pharmaceutical industry
Docusate sodium is a pharmaceutical grade surfactant, very efficient wetting, emulsifier, dispersing and solubilizing agent. Solvay offers Docusate sodium as:
- Docusate Sodium: waxy material 100% active
- Docusate Granular: powder 85% active combined with NF grade sodium benzoate
- Docusate in 23 Alcohol: liquid 75% active
- Docusate in PEG 400: liquid 50% active
Docusate sodium is an FDA approved excipient, which has proven effective in more than 50 unique formulations:
Dispersing agent for tablet manufacture
- Liquid or gel suspensions
- Effervescing tablets
- Emulsifier for creams and gels
In addition to excellent solubilizing, wetting, dispersing and emulsifying properties, docusate sodium gives a low order of toxicity and is stable and compatible with a wide range of pharmacologically active drugs
Docusate unmatched wetting power - Contact angles of Docusate vs. other surfactants
Docusate for poorly soluble API (BCS class II and IV)
Docusate sodium is also as a powerful solubilizing agent, helping the formulation of poorly soluble active ingredients (APIs). Many new APIs (reported to be 40-70%) have a poor aqueous solubility leading to reduced bioavailability. Reduced bioavailability has an efficacy and financial consequence, as patients are not receiving the benefits of the medication and companies are not able to take full advantage of expensive APIs. There is also an unforeseen impact on the environment as trace quantities of these APIs might find their way into the water table.
Docusate sodium can be used to overcome this bioavailability issue by improving solubility using a variety of manufacturing techniques such as wet granulating, nano milling and hot melt extrusion (HME). Solvay can provide formulation examples of these various techniques with BCS class 2 and 4. To learn more about Solvay’s industry-leading pharmaceutical grade docusate sodium surfactant, register to receive additional information or contact us to discuss your specific pharmaceutical application with one of our Solvay Novecare technical representatives.
Docusate sodium USP and Docusate Calcium USP are used extensively in stool softener formulations to provide consistent, predictable, and gentle relief. This highly effective and versatile anionic surfactant (surface active agent) is used as an active ingredient in a variety of combination laxative/stool softener formulations. Our pharmaceutical-grade Docusate products are manufactured to the highest quality standards under cGMP, and offer exceptional quality and performance as active ingredients.
Docusate is particularly effective as an active ingredient in:
- Laxatives & stool softeners – for prevention and treatment of various types of constipation, can be used alone or as an adjuvant with other laxatives, with a typical usage level of 0.1-1.0 % by weight
- Prenatal & geriatric vitamin preparations – to overcome constipation induced by iron salts
- Colon cleansing aids – in preparation of a patient for X-ray examination or surgery
- Ear wax removal – acts as a wetting agent to soften compacted wax
Pharmaceutical grade, manufactured under cGMP ; EP and USP compliant
Virtually free from adverse reactions when used in recommended doses
Effective alone or in combination with peristaltic stimulants and bulking agents
Docusate comes in 4 product forms:
Docusate Sodium 100% waxy material and 85% powder (Docusate Granular) for tablets
Docusate Sodium 50% in PEG 400 and Docusate Calcium 50% in Corn Oil for softgels
Meets standards of quality, strength, purity, and potency recognized worldwide
Causes the least possible disturbance of normal body physiology; non habit-forming
Allows ability to optimize formulations and enhance performance results
Multiple product types provide flexibility in handling and ease of use.