1334001 anamika
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Transcript of 1334001 anamika
A PRESENTATION ON Drug formulation Carried Out At - Himalaya Meditek PVT.LTD.Under the guidance : Mr. Bharat Raj Jha
Submitted to: Biotech Department KRG PG Autonomous College
Presented by Anamika gupta M.Sc.IV sem.
Over viewThe company is situated in an open space and no company providing obnoxious odors pollutants adjacent to the company.The facilities include raw and packaging materials warehouse, finished goods warehouse and Section for Tablets, Capsule, and Oral Liquid and Ointments. All the testing of raw, intermediate and finished goods is done in a well equipped laboratory. It has fully fledged utilities sections.Laboratories Limited is one of the manufacture of quality pharmaceutical has establish an ultra modern facility as GMP Standards to manufacture Tablets, Capsules, Liquid and Ointment.
The company has pharmaceuticals formulation plant situated at plot no. 35/36 Pharmacity Seliqui Dehradun
Quality Control
Quality control is the process by which entities review the quality of all factor involved in the production.
Quality control include the product inspection where every product is examined
Objectives of quality control
To establish the desired quality standard
To evaluate the old method and procedure for further improvement in their functioning
To detect the variation in the quality of raw material ,manufacturing process
Drug
Agent intended for use in the diagnosis, mitigation, treatment, cure or prevention of disease in man or in other animals.
It may be:1. synthetic 4. biological2. semi-synthetic 5. natural3. chemical
Generally, the drug is combined with other ingredients into a drug formulation, which may be a solution, tablet, capsule or suppository
Drug Action
Result of an interaction between the drug substance and functionally important cell receptors or enzyme systems. This response is due to the alteration in the biologic processes that were present prior to the drug administration.
Different form of drug
Solid dosage –tablet ,capsuleLiquid dosage -syrup
TabletA solid dosage form containing medicinal substance
Disadvantage Bitter taste Bad odor Slow disolution
properties
Advantage Tablets are easy to
be administered They are more
stable dosage form Easy to be
dispensed
Tablet
Types of tabletOn the basis of route of administration Buccal tablet-
That dissolve when hold between cheek and gum permitting direct adsorption of the active ingredient through oral mucosa.
Sublingual tablet- That dissolve when held beneath the
tongue permitting direct adsorption of the active ingredient through oral mucosa.
Different Excipients used in Tablets
1. Diluents – added to increase the bulk/mass of the dosage form ex. Lactose, Dibasic Ca Phosphate, starch, microcrystalline cellulose2. Binder – makes the diluent adhere to the tablet to form a
compact mass. Pressure is applied to make the tablets contact.
Ex. Acacia, alginic acid, gelatin, povidone, etc.3. Lubricant
– helps to have an easier transfer from one stage of manufacture to another - assist the smooth tableting process.Ex. Mag. Stearate, stearic acid, talc, hydrogenated vegetable oil
excessive magnesium stearate (a hydrophobic lubricant) in the formulation may retard drug dissolution and cause slower drug absorption.
Tablet Coating
protectionuneven coating can cause uneven release of active ingredient
Example:a. enteric coatings – employed to permit safe passage
of tablet through the acid environment of the stomach where certain drugs may be destroyed, to the more suitable juices of the intestines where tablet dissolution safely takes place. ( shellac, cellulose acetate phthalate)b. film-coatings
– employed to protect the drug substance from the destructive influences of moisture, light and air throughout their period of storage or to conceal a bad or bitter taste from the taste buds of the patient. (hydroxypropylmethylcellulose)
c. sugar-coatings – conceal bitter taste (liquid glucose, sucrose)
IN PROCESS QUALITY CONTROL
Equipments used in process quality control Friability test machineDisintegration test machine
Friability test The friability tester consist of an aerylic drum which rotates with fixed speed of 30 rev.per minute.Tablet to be tested ,weigh them and put them at the bottom of the drum .Adjust the timer and put the switch on.The drum rotates and the tablet falls,after 100 rev.unit will stop.Remove the tablet and weigh them again.The difference in weight indicates the rate of abrasion.
Disintegration test
The disintegration test is provided to determine wether the coated and uncoated tablets disintegrate within a prescribed experimental condition and prescribed time or not.
Disintegration is the physical break-up of an intact dosage form to its component aggregates.Disintegration depends on the disintegrant used.
Starch Microcrystalline cellulose
Method
Disintegration test machine consist of a wire mesh and a basket which consist of 6 tubes.1 tablet in each tube.Dip the basket rack assembly in water at temperature 37 degree celcius.Remove the basket,dry it thoroughly.Note that the time required for all the 6 tablet to disintegrate,no particles remain on the wire mesh.
Hardness tester
Hardness of a tablet is expressed in terms of load/pressure required to crush it when placed on its edge.It indicates the tensile strength of a tablet.Disintegration and dissolution times as well as affected by the tablet hardness.Ex.Pfizer hardness tester.
Dissolution test
Dissolution is the process by which a solid of only fiar solubility charecteristic enters in to the solution. The rate of dissolution of the solid substance is determined by the rate of diffusion of a very thin layer of saturated solution around the solid particle.