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Chapter 3 Characteristics

Chapter 3 Characteristics. C haracter of serial dosage forms: sterility and freedom from particulate matter are common character of serial dosage forms . Parenteral should be pyrogen free and stable . Particulate matter: cellulose, cotton fiber, glass, rubber, metal and plastics .

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Chapter 3 Characteristics

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  1. Chapter 3Characteristics

  2. Character of serial dosage forms: • sterility and freedom from particulate matter are common character of serial dosage forms. • Parenteral should be pyrogen free and stable. • Particulate matter: cellulose, cotton fiber, glass, rubber, metal and plastics. • Un dissolved chemicals: rust and dandruff.

  3. Biological significant: Clarity or absence of visible particle matter according to USP. • Sources of particulate matter: • The solution or chemical in it. • The manufacturing process: environment, equipment, personnel • The packaging component. • Sets and device used in administrating the product.

  4. Particles 50 micro m or larger can be detected by visual inspection. • For smaller particles, other techniques are used. • Membrane or microscopic method: • Pass the solution through a membrane filter, followed by microscopic examination of the particles retained on the membrane. • The method can be done by special device.

  5. USP microscopic membrane method is used for determination no of particle in LVP. • Method utilizing on electronic liquid – borne particle counting system, with a light obscuration sensor for SVP. • LVP= large volume parenteral • SVP= Small volume parenteral

  6. B.P. uses the coulter counter All the methods are comparable . • The LVP injection meets the stander if it contains not more than 50 particles per milliliter that are equal to or larger than 10 micrometer , and not more than 5 particle per milliliter that are equal to or larger than 25 micrometer in linear dimension . • The counting is done by using an electronic liquid-borne particle counter with a light-obscuration sensa….

  7. Freedom from pyrogens: Pyrogens cause headache and increased fever (serum fever) because of the presence of bacterial endotoxins. • Definition: Pyrogens or bacterial endotoxins are metabolic products of living microorganisms , or the dead microorganisms themselves, causing aspecific pyretic response upon injection chemically they are considered to be lipopolysaccharides , soluble in water but insoluble in organic solvents.

  8. Neither sterilization with moist heat under preasure nor filtration through sterilizing filters eliminates pyrogens. • Pyrogens produced by gram-negative microorganisms are the most potent. • Pharmacological effects: Rabbits had been used traditionally as the test animal in the official test for the detection of pyrogens.

  9. Source of pyrogens: • The water used as the solvent ( most common source of pyrogen) • The container and chemical • Packaging • Storage • Administration

  10. Because pyrogennot volatile . • Storage of water for injection (WFI) in pyrogen-free ,steril container at either 5c or 80c . • Or sterilize water for injection then label sterile WFI .

  11. Elimination of pyrogen: • Being organic compound pyrogen can be destroyed with high heat by oxidation or buringup satisfactorily are 180c for 3-4hrs. • This method is effective for and metal container contaminated with pyrogen. • It is not practical for solution • Pyrogen in solution are eliminated chemically by oxidation with peroxides , acid , and alkali with caution . • By adsorption of pyrogen in solution by asbestos and charcoal with caution.

  12. Pyrogen test : • Samples taken from each production batch • Rabbit is the experimental animal (3animal) • Sample of the parenteral solution are injected in to the ear vein

  13. Stability: • Drugs in solution tend to be less stable than those in the dry form. • Maintain physical and chemical stability. • Presence of ppt. or colors → instability. • Stability should be maintained during storage.

  14. 1. Lyophilization • Lyophilized products maintain stability. • The process of rapidly freezing and drying the frozen sterile solution of drug under high vacuum . • Drug solution + diluent e.g. mannitol →filtration / sterilization → Aseptically subdivided into the final sterile containers. Then the trays of containers are placed in Lyophilization chamber. The containers are aseptically removed and closed.

  15. 2. Spray drying • To prepare powders (sterile) for reconstitution under aseptic conditions. • A sterile solution of the antibiotic is sprayed into the top of a cone-shaped chamber through which warm air is circulating. The atomized droplets dry rapidly as they fall through the warm air. The spray dried particles are homogeneous, uniform in size, and nearly spherical in shape. After collecting the bulk sterile powder is subdivided into sterile containers

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