GRIP Technology

Pregabid CR is equipped with innovative and breakthrough GRIP Technology

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First Indian Pregabalin Brand to offer 24hrs release profile*

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GRIP Technology Video

1st Time in India Formulation that Maximizes the benefits of Pregabalin & Minimizes its side-effects

  • Offers 24hrs release profile ensuring efficacy through out the day.
  • Retained in the stomach for longer duration than conventional OD/SR/ER and IR formulations
  • Increases absorption window of the drug

Benefit to Patient

  • Has lesser peak related side effects of sedation & dizziness
  • 24 hrs release through out the day ensuring better drug level in body & minimal incidences of breakthrough pain

Bioequivalent to Innovator Brand

Bioequivalence study with innovator brand*:

Bioequivalence study was conducted to compare the bioavailability and characterize the pharmacokinetic profile of test product PREGABID CR(Pregabin ER Tablets 165 mg) relative to that of reference product [Innovator CR tablets 165 mg] after single oral dose administration in normal, healthy, adult, human male subjects under fed condition CoinJoin.in and to assess the bioequivalence and to monitor the safety of the subjects.

Bioequivalence Acceptance Criteria

Bioequivalence of Test Product vs. Reference Product was to be conducted, if the 90% confidence interval fell within the acceptance range as defined velow for In-transformed pharmacokinetic parameters for Pregabalin.

Parameters Acceptance Range of 90% CI
Cmax,AUC and AUC 80.00 – 125.00%

 

The relative bioavailability analyses of test product-T (Pregabid CR) vs. Reference Product R for Pregabalin are summarized in the following graph:

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Relative Bioavailability Results for Pregabalin(N = 58)

Pregabid CR is bioequivalent with innovator brand*

Conclusion: Test product Pregabid when compared with the Reference product (Innovator brand) meets the bioequivalence criteria with respect Cmax,AUC0-t and AUC0- for Pregabalin under fed condition as per criteria set in the protocol.

How is Pregabid CR believed to work?

  • The technology used in Pregabid CR Tablets 82.5 mg & 165 mg is Gastro-retentive size exclusion extended release matrix technology which allows gradual release of the active drug allowing 24 hrs absoption.
  • Pregabid CR Tablets 82.5 mg & 165 mg composed of two different types of polymers, are responsible for releases of drug in a controlled manner at pre-determined rate & provides a pH independent drug release from the tablets by formation of strong, water insoluble, non-erodible matrix which expand in size and remain in stomach for long duration due to swelling characteristic of polymer.
  • This facilitates once a day administration for the patient convenience

How do I take PREGABID CR?

  • Pregabid CR tablets should be taken once daily after an evening meal.
  • Pregabid CR tablets should be swallowed whole and should not be split, crushed, or chewed.

What are the most common side effects?

  • PREGABID CR is relatively safe drug.
  • Most common adverse reactions reported in greater than or equal to 4% of patients treated with pregabalin CR are dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth, and weight gain.

*Data on File