tablets evalution

Post on 09-Jan-2017

24 Views

Category:

Health & Medicine

0 Downloads

Preview:

Click to see full reader

TRANSCRIPT

1

PRESENTED TO PRESENTED BY

Dr. INDU SINGH GOVIND YADAV

Babasaheb Bhimrao Ambedkar University

Lucknow (Department of pharmaceutical

science)

A PRESENTATION ON Evaluation of Tablets

2

INTRODUCTION

EVALUATION OF TABLET Non-official Tests:

1) General appearance I) Organoleptic property II) Size & Shape 2) Hardness 3) Friability Official tests: 1) Weight Variation 2) Content uniformity 3) Dissolution 4) Disintegration

CONTENTS

3

INTRODUCTION Tablets:- Tablets are the solid unit dosage forms containing a medicament or mixture of medicament & excipients compressed or moulded into solid .

TYPE OF TABLETS :- I) Compressed tablets Ex: Coated & Uncoated tablets. II) Molded tablets Ex: Dispensing & Hypodermic tablets.

4

Evaluation of Tablets Non-official Tests: 1) General appearance I) Organoleptic property II) Size & Shape 2) Hardness 3) Friability Official tests: 1) Weight Variation 2) Content uniformity 3) Dissolution 4) Disintegration

.

5

1)GENERAL APPEARANCE: The general appearance of a tablet, its visual identity and overall “elegance” is essential for consumer acceptance, for control of lot-to-lot uniformity

Appearance of a tablet involved the measurements of a tablet’s:-

Size Shape Colour Odour Taste Surface texture

Non- official tests:

6

Many pharmaceutical tablets use color as a vital means of rapid identification and consumer acceptance

The color of a product must be uniform within a single tablets

I) ORGANOLEPTIC PROPERTIES

7

II) SIZE & SHAPE

Caliper scale

8

Tablets require a certain amount of strength, or hardness and resistance to friability, to withstand mechanical shocks of handling in manufacture, packing and shipping

Hardness thus sometimes termed the tablet crushing strength

Tablet hardness tester are:- Monsanto tester Pfizer tester Strong-cobb tester Erweka tester Scleuniger tester

2) HARDNESS

9

10

3)FRIABILITY The friability test is official in USP but not in BP

and IP

Friability tester is known as the Roche friabilator

Tablet hardness is not an absolute indicator

of strength since some formulations,when

compressed into very hard tablets

11

PROCEDURE:-

Roche friabilator

12

The weight of the tablet being made is

routinely measured to help ensure that a tablet

contains the proper amount of drug

As per indian pharmacopoeia (IP)

weight 20 tablets selected at random and

determine the average weight

1) Weight Variation

13

Not more than 2 of the individual weights

deviate from the average weight by more than

the percentage deviation shown in the table

14

The potency of tablets is expressed in the

terms of grams, milligrams, or micrograms of

drug per tablet and is given as the label

strength of the product Determine the amount of active ingredient by the

method in the Assay;

The result lies within the range for the content of

active ingredient stated in the monograph

2) Content uniformity

15

This test is applicable to tablets that contain

less than 10mg or less than 10% w/w of the

active ingredient

It is not applicable to tablets containing

multivitamin and trace element

16

Ten tablets are taken at random, there

content of active ingredient is determine in

each of 10 tablets and the average value is

calculated

The sample passes the test is not more than one of

the individual value is the out side the limit of 85

to 115% of the average value

As per IP:-

17

If two or three of the individual tablets are

outside limits 85 to 115% of the average value

and the none is the outside the limit 75 to 125%

The test is repeated using another 20 tablets

And none is outside the limit 75 to 125% of the

average value

18

In the total sample of 30 tablets

Not more than three of the individual values

are outsides the limit 85 to 115% and none is

outside the limits 75 to 125% of the average

value

19

3) DISSOLUTION

20

21

22

Dissolution test apparatus

23

4) DISINTEGRATION

24

25

pharmacopoeia

26

27

28

29

30

References Indian pharmacopoeia J. Swarbrick and J.C. Boylan, Eds , Encyclopedia of pharmaceutical technology vol 12 lachmanl, lieberman h.a. ‘the theory and practice of industrial pharmacy

Banker gs & Rhodes c.t., ‘Modern pharmaceutics’

31

Thank You

top related