Pregabalin 25 mg Capsule | Formulation & Manufacturing Process

Pregabalin is an anticonvulsant, analgesic, and anxiolytic medication used to treat epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome, opioid withdrawal, and generalized anxiety disorder (GAD). Pregabalin also has antiallodynic properties. Its use in epilepsy is as an add-on therapy for partial seizures. It is a gabapentinoid medication and acts by inhibiting certain calcium channels. When used before surgery, it reduces pain but results in greater sedation and visual disturbances. It is taken by mouth.

Pregabalin was approved for medical use in the United States in 2004. It was developed as a successor to the related gabapentin. It is available as a generic medication. In 2020, it was the 78th most commonly prescribed medication in the United States, with more than 9 million prescriptions. In the US, pregabalin is a Schedule V controlled substance under the Controlled Substances Act of 1970. It is a Class C controlled substance in the UK.

There are several dosage forms and strengths available with Pregabalin. One of the most common of which is Pregabalin 25 mg Capsule.

Each capsule contains Pregabalin BP 25 mg. The formulation & manufacturing process of Pregabalin 25 mg Capsule is as below:

Formulation:

Each capsule contains:

Sl	Name of the Ingredient(s)	Specification	Quantity	Function
Active Ingredient
1	Pregabalin	BP	25.00 mg
Excipients
2	Microcrystalline Cellulose (PH-101)	BP	100.00 mg
3	Lactose Monohydrate	BP	115.00 mg
4	Purified Talc	BP	5.00 mg
5	Colloidal Anhydrous Silica (200)	BP	2.50 mg
6	Magnesium Stearate	BP	2.50 mg
7	Empty Hard Gelatin Capsule Shell (Size # 2)	Pharma Grade	1.00 Pcs

** The formulation varies from Man to Man, Machine to Machine, Method to Method, and Materials to Materials.

Manufacturing Process:

1. Pass Pregabalin, Microcrystalline Cellulose 101 & Lactose Monohydrate through a 20-mesh and Purified Talc, Colloidal Anhydrous Silica 200 and magnesium Stearate through a 40-mesh sieve.
2. Blend Pregabalin, Microcrystalline Cellulose 101, Lactose Monohydrate, Purified Talc, Colloidal Anhydrous Silica 200, and magnesium Stearate in a Drum/Double Cone Blender for 30 minutes.
3. Fill the blended mix into an Empty Hard Gelatin Capsule Shell of Size # 2.
4. Send the sample of capsules to the Quality Control Department by an Analytical Test Request Sheet for necessary analysis & release for blistering.