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.