biotechnology ppt

1. 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.

2. Over view
The 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

3. 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

4. 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. biological
2. semi-synthetic 5. natural
3. chemical
 Generally, the drug is combined with other
ingredients into a drug formulation, which may be a
solution, tablet, capsule or suppository

5. 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.

6. Different form of drug
Solid dosage –tablet ,capsule
Liquid dosage -syrup
Tablet
A solid dosage form containing medicinal substance

7. Disadvantage
 Bitter taste
 Bad odor
 Slow disolution
properties
Tablet
Advantage
 Tablets are easy to
be administered
 They are more
stable dosage form
 Easy to be
dispensed

8. Types of tablet
On 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.

9. Different Excipients used in Tablets
1. Diluents – added to increase the bulk/mass
of the dosage form
 ex. Lactose, Dibasic Ca Phosphate, starch,
microcrystalline cellulose
2. 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.

10. Tablet Coating
 protection
uneven 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)

11. IN PROCESS QUALITY CONTROL
Equipments used in process quality control
Friability test machine
Disintegration 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.

12. 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

13. 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.

14. 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.

15. 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.