WITEPSOL H 15
Hard fat, Adeps solidusProduct Application: Capsule filling,Chewable Tablet,Implants,Microencapsulation,Ovule,SLN Processes,Suppository,Tablet
Product Certification: GMP,Halal,OU Kosher
Pharmaceutical Category: Solid triglycerides
WITEPSOL H 15 is a product in the H series of WITEPSOL which are hard fats with hydroxyl values up to 15. They mostly consist of triglycerides with a portion of, at most, 15% of diglycerides and not more than 1% of monoglycerides. They are characterized by a very small gap between the melting and solidification temperatures, have only a minor tendency to the post hardening phenomenon (maximum 1.5 °C) and can be processed both with automatic casting machines and, on a small scale, using the cream melting process (precrystallization) at casting temperatures around the stated melting point. Shock cooling should be avoided. This series of grades also includes compounds having hydroxyl values (HV) between 0 and 5 which avoid interactions between the free OH groups and acidic active compounds (ASS, Diclofenac, etc.).
WITEPSOL H 15 has a hydroxyl value of 5-15. It is used as a compound for suspension suppositories having a proportion of solid active compounds of less than 25%.
Hard fat recommendations for commonly used active pharmaceutical ingredients:
- Actives for malaria treatment
- Anti-inflammatory substances
- Antidepressants (alkaloids)
- Antiepileptics (barbiturates)
- B vitamins
- β-lactam antibiotics
- Male hormones
- Nonsteroidal anti-inflammatory drugs
- Steroidal antirheumatics (corticosteroids)
Slip Melting Point (°C): ~35
Melting Point (°C): ~35
Molten WITEPSOL® behaves approximately like a Newtonian liquid; the measured shear stress is almost linearly dependent on the applied shear rate. The viscosity is lower for the H grades then for the partial glycerides containing W grades. S grades have a slightly higher viscosity due to the emulsifier content:
Comparison of the rheological behavior of pure WITEPSOL® grades:
Viscosities as a function of temperature for suppository bases, exhibiting an open-tube melting point of:
WITEPSOL H 15 contains – besides triglycerides (C36–C54) – monoglycerides (< 1%) and about 10% of diglycerides, corresponding to a hydroxyl value of about 10. Higher hydroxyl values can be expected due to higher amounts of diglycerides (for example WITEPSOL® W 35) or additionally by means of an increased proportion of monoglycerides (for example WITEPSOL® W 45).
Glyceride distribution of WITEPSOL® H 15: