Divule

DIVULE

Divule^® is a dosage form that consists of a high-gloss gelatine coating that encases a caplet core, which results in a capsule that looks like a tablet.

It combines the qualities of a gelatine capsule with the density of a tablet, creating an exciting new dosage form that can be custom engineered to meet specific product performance criteria.

The outside gelatine shell is taste-free, and is backed by decades of safe and effective utilization in oral dosage applications. Moreover Divule has the advantage to be divisible if necessary.

Divule^® is a trademark of S.M.B.

Example: First BREAKABLE Fluoxetine

Start and adjustment of treatment: The starting dose is 20 mg daily. In patients with incomplete response but good tolerability at lower doses, dosage adjustments should be made in 10 mg increments over a period of several weeks. The usual antidepressant dose is 20 mg to 60 mg daily.

End of treatment: Withdrawal reactions have been reported with all SSRIs. Common symptoms include dizziness, paraesthesia, headache, anxiety and nausea. Abrupt discontinuation of treatment should be avoided. Dosage decrease should be made in 10 mg increments over a period of several weeks.

In addition to the ones mentioned above,  SMB and Galephar have more recently developed new formulations keeping the same lobjective in mind : to impove quality, efficacy and/or patients’ compliance.

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MISCELLANEOUS

• SUBLINGUAL TABLETS

A sublingual tablet is a special formulation which has the particular feature of dissolving rapidly when in contact with saliva in order to release the active ingredient orally.

This formulation might be required:

• For molecules sensitive to acidic environment
• To avoid hepatic first-pass effect
• To obtain a rapid effect thanks to the thin sublingual membrane and its high vascular flow

Manufacturing process

The process used to manufacture sublingual tablets is wet granulation which, compared to direct compression, allows to increase the powder density and to regularize its flowability. Besides, it allows optimizing the homogeneity of the mix and to avoid demixing phenomena.

Briefly, the ingredients are mixed together while the active substance is being dissolved and then added to the mix in an adequate mixer. The granulates are then dried and sieved. Additional excipients are added and the powder blend obtained is tabletted.

Example: Buprenorphine HCl

Buprenorphine is indicated for the treatment of opioid dependence and the goal was to obtain a formulation essentially similar to the originator. But the latter has the inconvenient to have a shelf-life of only twelve months  a very short time of use between the time of the  manufacturing process and the moment when the patients actually take it.

Taking this into account, we developed a formulation with improved stability providing a shelf-life of up to four years.

• FLAPULES: oily solution of vitamin D3 for oral administration (Cholecalciferol 25,000 IU/dose)
• POWDER SACHETS: paracetamol, paracetamol+caffeine, paracetamol+codeine
• THROAT SPRAY : chlorhexidine+Lidocaine spray
• SYRUPS