CHLORDIAZEPOXIDE CAPSULE

August 29, 2020

Capsules: Capsule are solid-dosage forms that are available in two types – hard (two-piece) or soft (one piece). The major component of the capsule shell is gelatin. The use of capsules avoids many unit operations that are associated with the manufacture of tablets, e.g. compression, granulation, drying. Capsules may be formulated to increase the oral bioavailability of poorly soluble therapeutic agents.

Theory: Diluents are employed in the formulation of tablets, capsule to increase the mass of the tablets that contain a low concentration of therapeutic agent and thereby render the manufacturing process more reliable and reproducible.

Glidants are used to lower the interparticle attraction, thereby reducing clumping and aiding powder flow.

Chlordiazepoxide capsules USP are indicated for the management of anxiety disorders or for the short-term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety.

Formula:

SR NO.	INGREDIENTS	QUANTITY	ROLE
1	Chlordiazepoxide	10mg	Sedative, antidepressant
2	Magnesium trisilicate	2mg	Glidant
3	Lactose	qs for one capsule	Diluent / Filler

Procedure:

1. Calculate required amount of lactose and weighed them accordingly.

2. Triturate chlordiazepoxide and magnesium trisilicate separately. Weigh both the trituration and mix in geometric proportion.

3. Add calculated quantity of lactose to above mixture and mix properly.

4. Fill the blend carefully ensuring that capsule is properly closed.

Molecular formula: C₁₆H₁₄ClN₃O

Appearance: Crystals or off-white powder

Dose:

ADULTS	USUAL DAILY DOSE
Relief of Mild and Moderate Anxiety Disorders and Symptoms of Anxiety	5 mg or 10 mg, 3 or 4 times daily
Relief of Severe Anxiety Disorders and Symptoms of Anxiety	20 mg or 25 mg, 3 or 4 times daily
Geriatric Patients, or in the presence of debilitating disease.	5 mg, 2 to 4 times daily

PEDIATRIC PATIENTS	USUAL DAILY DOSE
Because of the varied response of pediatric patients to CNS-acting drugs, therapy should be initiated with the lowest dose and increased as required. Since clinical experience in pediatric patients under 6 years of age is limited, the use of the drug in this age group is not recommended.	5 mg, 2 to 4 times daily (may be increased in some pediatric patients to 10 mg, 2 to 3 times daily)