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;
- 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.
- 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.
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)).
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).
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).
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