mayne pharma

Pellet Technology Study

The following case study highlights how use of Pellet technology reduces the symptoms of nausea and provides patients with smooth steady-state plasma levels.

The mode of action of delayed release pellets can be demonstrated as follows;

  1. Enteric coated capsule dissolves and releases approximately 300 coated pellets. The pellets which are resistant to the gastric juice due to the polymer coating, are gradually distributed in the stomach.
  2. Because of their small size, the pellets pass easily through the pylorus. The specific milieu of the duodenum with pH levels 6-7, causes the enteric-coating to disintegrate, and the active pharmaceutical ingredient is rapidly absorbed.

 

Pellet Technology - Delayed Release

The following graph demonstrates that compared to Vibramycin™, which is supplied in a conventional capsule formulation, controlled-release pharmaceutical Doryx™, supplied in pellet form, significantly reduces the effects of nausea.

Incidence of nausea induced by Vibramycin™ 100mg, Doryx™ 100mg capsules and placebo
(all doses administered without food, (n=97)).

Pellet Technology Graph 1

Source:  Story MJ, McCloud PI and Boehm G. Doxycycline tolerance study - incidence of Nausea after doxycycline administration to healthy volunteers: A comparison of 2 formulations (Doryx vs vibramycin). Eur J Clin Pharmacol, 1991 (40: 419-421)

Benefits of pellet technology are further showcased through a trial with Kapanol™ / Kadian™ capsules, whose drug delivery profile is achieved with Mayne Pharma’s sustained release pellet technology, and provides patients with smooth steady-state plasma levels for consistent pain relief compared to morphine in either a controlled release tablet or oral solution form.

Mean steady state plasma morphine concentrations for Kapanol™ / Kadian™ capsules, controlled release morphine tablet and oral morphine solution.
Plasma concentrations are normalised to 100mg every 24 hours, (n=24).
Kapanol™ / Kadian™ capsule (twice a day), controlled release morphine tablet (twice a day) and oral morphine solution (every 4 hours).

Pellet Technology Graph 2

Source: Gourley GK, Plummer JL, Cherry DA, et al. A comparison of Kapanol (a new sustained-release morphine formulation), MST Continus, and morphine solution in cancer patients: pharmacokinetics aspects of morphine & morphine metabolites. In: Gebhart GF, Hammond DL, Jensen TS, editors. Progress in pain research and management. Seattle (WA): IASP Press, 1994 (631-43).

Please note this information is intended for potential licensees. 


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