Preparation and evaluation of Tetracycline capsules
BP506P Industrial Pharmacy I Practical
Aim: To Prepare and evaluate 250mg tetracycline capsules.
Capsules are solid dosage forms in which a drug or mixture of drugs is enclosed in a hard gelatin capsule shell, in the soft, soluble shell of gelatin, or in the hard or soft shell of any other suitable material, of various shapes and capacities: They usually contain a single dose of active ingredient(s) and are intended for oral administration
Tetracycline is a yellow, odourless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Tetracycline is very slightly soluble in water, freely soluble in dilute add and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. Tetracyclines are readily absorbed and are bound to plasma protein in varying degrees. They are concentrated by the liver in the bile and excreted in the urine and faeces at high concentrations in a biologically active form.
Tetracycline hydrochloride is a prescription antibiotic used to treat a wide range of infections. It’s effective against a broad spectrum of bacteria, as well as other organisms, including some protozoan parasites. Tetracycline has commonly been used to treat acne and other skin infections; respiratory tract infections such as pneumonia; genital and urinary infections; and Helicobacter pylori (the bacteria that can lead to stomach ulcers)) It’s also sometimes used for treating Lyme disease and for preventing anthrax infections. The first drug in the tetracycline family, chlortetracycline was introduced in 1948. Overuse of tetracycline (and other antibiotics) in humans and farm animals have allowed some bacteria to build up a resistance to antibiotics.
Doctors are now strongly advised to prescribe tetracycline only when there is proof, or a strong suspicion, that bacteria not a virus – is causing an infection. Since tetracycline does not work for colds, influenza (flu), or other viral infections, if you take it for these conditions, you may be promoting the development of drug-resistant diseases while doing nothing to help your illness.
Synonym: Tetracycline HCl, Achromycin.
Formulation of tetracycline capsules
|Ingredients||Qty given/Capsule||Qty taken (No. of capsules x Quantity given)|
Mortar and pestle, empty capsules, sieve, hand operated capsule filling machine, volumetric flask, pipette, beaker, stop watch, measuring cylinder, Whatinan filter paper, UV spectrophotometer, Disintegration test apparatus.
- Weigh the required quantity of drugs and other excipients.
- Moisture content should be less than 1.5%.
- Starch should be dried and sieved through 100*, moisture less than 1.5%
- Talcum should be dried and sieved through 100S, moisture less than 1%.
- Mix all the ingredients uniformly using a mortar and pestle.
- Empty capsule shells of the number “0” are selected for filling the content in the capsule shell.
- Store capsules in an airtight container.
Category: Antibiotic capsule.
Dose: Tetracycline is taken by mouth as a capsule or liquid, typically two to four times a day for seven to 14 days.
- The usual dose of tetracycline for adults is 1-2 grams per day in two or four divided doses.
- You should take tetracycline on an empty stomach with a half glass of water. Take the drug at least one hour before or two hours after meals or snacks.
Storage: Store in a tightly closed container in a cool and dry place.
Packaging: In a plastic bottle.
Evaluation of Hard Gelatin Capsule
- Disintegration Time: One capsule was placed in each of six tubes of assembly and the assembly was suspended in water. Discs were added to each tube, the temperature was maintained at 37±2°C and assembly was operated for 60 min.
- Drug Content: Weigh an amount of the granules equivalent to 50 mg of losartan potassium was dissolved in 100 ml of phosphate buffer pH 6.8, filtered, diluted suitably and analyzed for the drug content at 246 nm using a UV-visible spectrophotometer.
- In-vitro Drug Release Study: The release rate of losartan potassium from granules was determined using IP Dissolution Test Apparatus Type II (basket type). Granules were first incorporated in an empty hard gelatin capsule of size #3 and then placed in a dry basket at the beginning of each test. Lower the basket in the dissolution medium and the apparatus was run at 50 rpm, The dissolution test was performed using 900 ml of phosphate buffer pH 6.8, at 37±0.5ºC and 50 rpm. 5 ml were withdrawn at time intervals of five minutes for 60 minutes. This was maintained at the same temperature and was added to the bulk. The samples were filtered through Whatman filter paper no. 41. The absorbance of these solutions was measured using UV- visible spectrophotometer. Cumulative percentage drug release was calculated using an equation obtained from a standard curve.
Industrial Pharmacy I Practical
- Preformulation studies on paracetamol/aspirin/or any other drug
- Preparation and evaluation of Paracetamol tablets
- Preparation and evaluation of Aspirin tablets
- Coating of tablets- film coating of tables/granules
- Preparation and evaluation of Tetracycline capsules
- Preparation of Calcium Gluconate injection
- Preparation of Ascorbic Acid injection
- Quality control test of (as per IP) marketed tablets and capsules
- Preparation of Eye drops/ and Eye ointments
- Preparation of Creams (cold / vanishing cream)
- Evaluation of Glass containers (as per IP)
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