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Witepsol E85
"Descrizione"
by A_Partyns (12876 pt)
2023-Aug-19 13:21

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Witepsol E85 is an inert hard fat used as base for drug release i.e. from suppositories progesterone.

The name defines the structure of the molecule

  • "Witepsol". It is the trade name for a series of suppository bases, which are mixtures of solid lipids used to formulate pharmaceutical suppositories.
  • "E85". This number indicates a specific formula or variant within the range of Witepsol products. Typically, the number may indicate the proportion of certain components or the physical properties of the product, such as the melting point.

The quantities normally used are 1.1275 g for 125 mg suppositories, 1.15 g for 250 mg oral medicines (1).

Description of the raw materials used in its production.

  • Triglycerides - These are the main components of suppository bases.
  • Fatty Acids - Used to modulate the consistency of the bases.
  • Antioxidants - For example, BHA (Butylated Hydroxyanisole) or BHT (Butylated Hydroxytoluene), used to prevent oxidation.

Step-by-step summary of its industrial chemical synthesis process. 

  • Purification of Raw Materials - The fatty acids and triglycerides are purified.
  • Mixing - The fatty acids and triglycerides are mixed in a specific ratio.
  • Heating - The mixture is heated to homogenize it and facilitate the melting of the components.
  • Addition of Antioxidants - Antioxidants are added to prevent oxidation.
  • Cooling - The mixture is cooled to allow solidification.
  • Packaging - The solid suppository base is packaged in appropriate containers.
  • Quality Control - The final product undergoes various quality checks to ensure it meets specifications.

The only problem with this grease is its oxidation when left in contact with air for a long time. It is therefore necessary to use the drugs that contain it in a short time.

Commercial applications

Suppository Base. Witepsol E85 is used in the production of suppositories, acting as a vehicle for the delivery of active ingredients.

Pessary Base. Used in the production of pessaries, solid formulations inserted into the vagina for the local release of drugs.

Emollient in Cosmetic Products. It can be used in cosmetics as an emollient agent to soften and smooth the skin.

Lipstick Base. Used in the production of lipsticks, acting as a solid base for the formulation.

Component in Skin Care Products. It may be used in formulations of skin care products for its ability to form a barrier on the skin.

Studies

Aminolevulinic acid-loaded Witepsol microparticles manufactured using a spray congealing procedure: implications for topical photodynamic therapy.  Al-Kassas R, Donnelly RF, McCarron PA.  J Pharm Pharmacol. 2009 Sep;61(9):1125-35. doi: 10.1211/jpp/61.09.0001.

Preparation and in vitro-in vivo evaluation of Witepsol H35 based self-nanoemulsifying drug delivery systems (SNEDDS) of coenzyme Q(10).
Nepal PR, Han HK, Choi HK.
Eur J Pharm Sci. 2010 Feb 19;39(4):224-32. doi: 10.1016/j.ejps.2009.12.004.

Release property of progesterone from a mixed-base suppository consisting of Witepsol W35 and Witepsol E85.  Iwata M, Komiya S, Nakamura K, Kiuchi M, Andoh N, Hirahara F, Maitani Y, Takayama K.  Drug Dev Ind Pharm. 2001 Nov;27(10):1039-45.

Optimization of the production of solid Witepsol nanoparticles loaded with rosmarinic acid.  Campos DA, Madureira AR, Gomes AM, Sarmento B, Pintado MM.  Colloids Surf B Biointerfaces. 2014 Mar 1;115:109-17. doi: 10.1016/j.colsurfb.2013.10.035

Effect of different bile salts on the relative hypoglycemia of witepsol W35 suppositories containing insulin in diabetic Beagle dogs.  Hosny EA, Al-Shora HI, Elmazar MM.  Drug Dev Ind Pharm. 2001 Sep;27(8):837-45.

Investigation of diazepam lipospheres based on Witepsol and lecithin intended for oral or rectal delivery.  Sznitowska M, Janicki S, Gajewska M, Kulik M.  Acta Pol Pharm. 2000 Jan-Feb;57(1):61-4.

References_______________________________________________________________________

(1) Ba B, Gaudin K, Désiré A, Phoeung T, Langlois MH, Behl CR, Unowsky J, Patel IH, Malick AW, Gomes M, White N, Kauss T. Ceftriaxone Absorption Enhancement for Noninvasive Administration as an Alternative to Injectable Solutions.    Antimicrob Agents Chemother. 2018 Nov 26;62(12). pii: e01170-18. doi: 10.1128/AAC.01170-18.

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