CHLORDIAZEPOXIDE CAPSULE
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) |
Category: Sedative, antidepressant
Drug class: Benzodiazepine
Contraindications: Chlordiazepoxide capsules are contraindicated in
patients with known hypersensitivity to the drug and intolerance to lactose.
Warnings: Product may cause drowsiness. Avoid driving or operating machines. Avoid alcoholic drinks.
Side effects: Drowsiness, loss of control of body movements
(ataxia), confusion.
Shelf life: 24 months
Storage: Store below 25°C.
Container: Opaque bottle
Brand name: Librium, Mitran, Multum
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