4. Elixer types of elixir and also test .pptx

AsadullahMehar1 140 views 33 slides Apr 16, 2024
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About This Presentation

Elixir define full detail view


Slide Content

Elixirs Elixirs are cle a r , sweetened hydro alcoholic solutions intended for oral use and are usually flavored to enhance their palatability. Elixirs are used as Flavor & Vehicle

Composition of Elixirs The main ingredients of Elixir are Water and Ethanol but Glycerin, Sorbitol, PG, Flavoring Agents, Preservative and Syrups are also used

Medicated elixirs contained the medicinal substances and they are used for the therapeutic effect. e.g. Antihistaminic Elixir like Chlorphenaramine meleate elixir

Sedative and Hypotonic Elixir e.g. Pediatric chloral hydrate Elixir Expectorant e.g. Terpin Hydrate Elixer Analgesic Elixir e.g. Acetaminophen Elixir

2) Non-Medicated Elixirs

Quality Control tests for Elixir

Alcohol Determination Viscosity Weight Per ml Assay of Active Ingredients

Elixir usually contains 5 to 40% alcohol. The determination of alcohol unless otherwise specified in the individual monograph. It is suitable for examining most fluidextracts and tinctures and elixirs provided the capacity of the distilling flask is sufficient (commonly two to four times the volume of the liquid to be heated) and the rate of distillation is such that clear distillates are produced. Cloudy distillates may be clarified by agitation with talc, or with calcium carbonate. And filtration is done. After which the temperature of the filtrate is adjusted and the alcohol content determined from the specific gravity. During all manipulations, take precautions to minimize the loss of alcohol by evaporation. For Liquids it is Presumed to Contain less than 30% of Alcohol.

Viscosity is a property of liquids that is directly related to the resistance to flow. viscosity measurement is very important quality control test in case of syrups an elixirs. viscosity and consistency directly relates with stability of solutions. ⦿ viscosity chance of stability.

Absolute viscosity: Measure when all the specifications and parameters are defined. Relative viscosity: Measure when we take any standard and make comparison. But no decisions are made after taking relative viscosity.

The resistance to flow encountered when one layer or plane of fluid attempts to move over another identical layer or plane of fluid at a given speed. Dynamic viscosity is also called absolute viscosity. Kinametic viscosity: Addition and deletion of force is known as the kinematic viscosity.

Methods used for Measurement of Viscosity

 

Falling Sphere Viscometer Principle: The principle of this instrument is based on stock’s law which state’s that “when a body falls through a viscous medium it experiences a resistance or viscous drag which opposes the motion of body”. At initial state body experiences acceleration due to gravity but soon this acceleration is balanced by viscous drag & body falls with a uniform terminal velocity .

Construction & working: * It consist on a tube having 2 marking A & B on the outer surface. * The tube is filled with liquid whose viscosity is to be determined. * The tube is clamped vertically inside a constant temperature bath & significant time is allowed or equilibrium of temperature & removal of air bubble from the liquid. * A ball (glass-steel) is allowed to fall through tube. * Time taken by ball to fall from point A to B is noted & terminal velocity is calculated. * This is obtained by dividing distance between the 2 points with time.

Falling Sphere Viscometer

Types

B. Cone & Plate Viscometer: It consists of flat circular plate with a wide angle cone placed centrally above it. During operation the sample is placed at the center of plate which is then raised into position under the cone. The cone is driven by variable speed motor & sample is sheared in the narrow gap between stationary plate & rotational cone. The rate of shear is rpm & is increased or decreased & torque produced is measured.

Pharmaceutical Importance: Predict flow properties of material How to handle the material Predict the pourability of oral dosage form Predict the Stability of dosage form Syrups: They having a specific value of viscosity if is change due to degradation of formulation then by measuring viscosity we can claim its formulation. Suspensions: Due to flocculation the viscosity can be change. Emulsion: Due to coalescence the viscosity can be change.

ASSAY & CONTENT UNIFORMITY This test is used to confirm that every unit should contains same amount of drug or active ingredients with little variation in the batch. Principle The test of the uniformity of the content of single dose preparations is based on the assay of individual contents of active substance(s) of a number of dosage units to determine whether the individual contents are within the limits set with reference to the average content of the sample.

ASSAY & CONTENT UNIFORMITY

Test A: For tablets, powders for parenteral use, ophthalmic inserts, suspension for injection. The preparation complies with the test if each individual content is between 85-115% of the Average content. The preparation fails to comply with the test if more than 1 individual content is outside 85 115% of the average content or if 1 individual content is outside 75-125% of the average content.

Test A: If 1 individual content is outside the limit of 85 115% but within the limit of 75-125%, determine the individual content of another 20 dosage units taken at random. The preparation complies with the test if more than 1 individual contents of the 30 units is outside 85-115% of the average content and none is outside the limit of 75-125% of the average content.

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