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Pellets

The technology

SMB’s pellets are pharmaceutical microgranules (from 0,5 to 2 mm) manufactured by a granulation-extrusion- spheronisation process.

SMB’s pellets are composed of a core containing the active ingredient and a porous membrane made of insoluble methacrylic polymers, which explains the controlled-release properties of these pellets.

Major advantages of pellets vs. regular tablets

  • Prolonged release during 24 hours – once daily administration.
  • It delivers steady plasma levels hour by hour for day and night control.
  • Therapeutic effect independent from food intake.
  • Better compliance.
  • Good tolerability; it reduces side effects by maintaining plasma levels within the therapeutic zone.
  • Stable therapeutic effect.
  • Possibility of developing different dosage strengths.
  • Pellet-released active ingredients may offer a higher bioavailability than usual drugs.

Brief description of the release process

The capsule first dissolves in the stomach, releases its pellets which disperse and pass to the small intestine. Water is absorbed through the porous membrane of each pellet and dissolves the active ingredient in the core.

As the pellet transits through the small and large intestines, the active ingredient is slowly dissolved and released by diffusion through its membrane. The capsule contains a homogeneous mixture. The pellet is based on a porous core of active ingredient and excipients that favour its solubility. This core is surrounded by a polymeric membrane that possesses controlled hydrophilic properties. When the pellet reaches the gastrointestinal tract, the core absorbs water through the polymeric membrane, which becomes a gel. Water flows in by osmotic pressure independently from pH levels. Within the core, a saturated solution builds up and the active ingredient is released by passive diffusion. The pharmacokinetic profile is independent from the food intake.

Examples :

TRAMADOL Once-a-day

Tramadol LP 200 mg is a prolonged release form of Tramadol HCl having a significantly lower Cmax and a significantly longer Tmax than the marketed immediate release capsule. The bioavailability of both formulations are comparable because the AUC∞ and AUCT of the prolonged release and immediate release forms are similar.

CLARITHROMYCIN prolonged release formulation

Clarithromycin is indicated in the treatment of lower and upper respiratory tract infections. The aim of SMB development was to develop a formulation suitable for once daily administration.

Advantages of Clarithromycin SMB:

  • Once a day formulation
  • Lower dose with the same proven clinical efficacy and safety versus originator
  • Pharmacokinetic profile always within the M.I.C in order to maximize efficacy and prevent microbial resistance