Venlafaxine SR Pellets

Venlafaxine SR Pellets – Suitable for filling in 37.5mg, 75mg & 150mg Capsules

  • MKPPL has developed venlafaxine pellets equivalent to innovator product Effexor-XR using aqueous technology.
  • Venlafaxine pellets were formulated using the technique of extrusion and Spheronization. Extrusion eliminates dust during formulation and yields high quality pellets.
  • Sustain release polymer coating is applied to control the release of drug for extended period of time.
  • The dissolution is performed up to 20 hrs. with intermittent intervals as per USP monograph.
  • Offer complete technical package for registrations in all regulated/semi regulated markets.

Venlafaxine Pellets 32% w/w

Venlafaxine is a selective serotonin and norepinephrine reuptake inhibitor (SNRIs) antidepressant. Venlafaxine is used to treat major depressive disorder, anxiety, and panic disorder.
Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent.

The Innovator

Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI).

Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethyl cellulose, gelatin, Hypromellose, iron oxide, and titanium dioxide.

MKPPL has developed Venlafaxine Pellets equivalent to innovator product using aqueous technology.
The strength of the pellets is: 32.0% w/w for dose of 37.5 mg, 75 mg and 150 mg with average capsule fill weight 117 mg, 234 mg and 469 mg.

Venlafaxine pellets were formulated using the technique of Extrusion and Spheronization. Extrusion eliminates dust during formulation and yields high quality pellets. Sustain Release polymer coating is applied to control the release of Drug for extended period. The dissolution is performed up to 20 hrs. with intermittent intervals as per USP monograph. In the formulation of pellets Lactose, PVPK-30, Sodium lauryl sulfate etc., are used in different concentrations. With respect to description the pellets are semispherical in shape.

Additional Information

Percentage

32%, 33%

Quality Standard

USP43

Documentation Available:

DMF in CTD Format

Release Type

Extended Release

Forms of PFI

Pellets/Micro pellets (for capsules)

Target Formulations

Capsules

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