Modified dosage forms are used in the case of drugs having rapid absorption, distribution, metabolism and secretion. If the drug is moved rapidly from the site of injection, viscosity enhancers should be added to slow down the movement.
If the drug stored in cold conditions, care must be taken that the drug is soluble at low temperatures.
Hyperalimentation Solution. Development of Subclavian vein cannulation- infused fluid is rapidly diluted by the high blood flow in the subclavian vein. Cardioplegia Solution. Are typically electrolyte solutions, where electrolyte composition is intended to maintain diastolic arrest. Peritoneal Dialysis Solution.
The process is employed to counteract some forms of drug or chemical toxicity as well as to treat acute renal insufficiency. An antibiotic is often added to these solution as a prophylactic measure. Irrigating Solutions. Although certain IV solutions, such as normal saline, may be used as irrigating solutions should not be used parenterally.
References: 1 Remington The Science and Practice of Pharmaceutical sciences, 21st edition Lippincott William Wilkins publishers, page no to 2 Indian Pharmacopoeia volume1, Published by controller of Publications, page no. The quality of parenterals is the sum of all parameters that contribute to safety, efficacy and therapeutic efficacy of the drug. The USP compendial requirements has recommended the following tests for parenteral products 1.
Weight variation or content uniformity 2. Particulate matter in injections 3. Bacterial endotoxin test 4. Pyrogen test 5. Sterility test. This test is intended for sterile solids used for parenteral preparation. The weight of 10 individual sterile units is noted and the content is removed from them and empty individual sterile unit is weighed intern.
Then net weight is calculated by subtracting empty sterile unit weight form gross weight. The content of active ingredient in each sterile unit is calculated by performing the assay according to the individual monographs.
The content in 10 sterile units is calculated by performing the assay. The dose uniformity is met if the amount of active ingredient is within the range of If one unit is outside the range of The preparations intended for parenteral use should be free form particulate matter and should be clear when inspected visually.
Two methods are described by USP according to the filled volume of the product to be tested. LAL Limulus Amebocyte Lysate test is used to characterize the bacterial endotoxin that may be present. The LAL reagent is used for gel-clot formation. The test is performed using stated amounts of volumes of products, standard, positive control, negative control of endotoxin.
When the tubes are inverted at C angle, formation of firm gel confirms positive reaction. Drugs administered as parenteral solutions are prepared as either small-volume or large-volume products.
They are packaged in these large volumes because larger quantities are typically required. Common LVPs include solutions needed to correct electrolyte and fluid imbalances, provide important nutrients or act as a vehicle for the delivery of other drugs.
The most common examples include sodium chloride solution, dextrose solution, Ringer's solution, and lactated Ringer's solution, as well as combinations of dextrose and sodium chloride. The market for LVPs is expanding due to an increase in the numbers of surgeries performed and the growing numbers of patients with chronic and other lifestyle-related diseases requiring hospitalizations.
A growing preference by patients for single-dose administration of vaccines and drugs to treat chronic diseases is also driving demand for LVPs. The company will supply these centers with mL solutions during Grifols is also offering this important LVP to hospitals, pharmacies and compounding centers in the US. Minibags 50 mL, mL and mL will be available soon.
Despite the growing interest in LVPs, only a few manufacturers produce these important products for the US market. In fact, increased demand in combination with manufacturing delays and other problems has led to shortages of key LVPs in the United States. Production of sterile injectable drugs must occur in highly controlled environments in accordance with current good manufacturing practices.
Extensive process understanding is required to ensure the consistent manufacture of high-quality products. Advanced quality programs combined with state-of-the-art automated aseptic processing systems are essential. Grifols has been manufacturing parenteral products, including LVPs such as sodium chloride 0. To ensure the highest quality, the company has adopted a vertical integration model for control of the entire manufacturing process and implemented automation technologies robotics and advanced process controls e.
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