Directly Compresible Vehicle By Mr. Vishal Shelke
https://youtube.com/vishalshelke99
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Introduction
These are the diluents or fillers designed to make up the required bulk of the tablets.
These are inactive ingredients that are added to tablets in addition to the active drug.
Some very common diluents in tablets include lactose and their derivatives, starch, cellulose derivatives.
Used in the direct compression of the tablets.
Requirements For A Good DCV :
Non-toxic and acceptable to the regulatory agencies.
Low cost.
Physiologically inert.
Must be color-compatible
Stability.
Controlled particle size.
Good flowability.
What is Direct compression ?
Direct compression (DC) is the tabletting of a blend of ingredients i.e. the compression mix, without a preliminary granulation or aggregation process.
The compression mix contains the active pharmaceutical ingredient (API) blended with one or more excipients.
The excipients may include binders, fillers/diluents, disintegrant and lubricants.
Advantages of DC :
More Economic compare to wet granulation since it requires fewer unit operations.
Documentation and validation requirements are reduced.
It requires less equipment, and space, time.
lower power consumpation , and less labor leading to reduce production cost of tablets.
More suitable for moisture and heat sensitive APIs, since it eliminates wetting and drying steps.
Lower microbial contamination
Faster drug release.
Disadvantages of DC :
Segregation because of the difference in the density of the API and excipients.
The dry state of the material during mixing may induce static charge and lead to segregation. due to this problems like weight variation and content uniformity may occur.
APIs that have poor flow properties and low bulk density is difficult to process by direct compression.
DC excipients are costly because these are prepared by spray drying, fluid bed drying, roller drying or co-crystallization.
Classification of DCV:
Disintegrants And Poor Flow:
ex. Microcrystalline cellulose , Starch.
Free-flowing Materials That Do Not Disintegrate :
ex. Dicalcium phosphate dihydrate.
Free-flowing Powders That Disintegrate By Dissolution:
ex. Lactoses,Sucrose, Dextrose Sorbitol , Mannitol
Co-processed exicipients :
ex. Ludipress
REFERENCES -
* Pharmaceutical dosage forms tablet Vol-II second edition lachman leon, lieberman H.A. Page.No 77-160.
* www.authorstream.com
STERILITY TESTING OF PHARMACEUTICALS ppt by DR.C.P.PRINCE
Directly Compresible Vehicle By Mr. Vishal Shelke
1. 1
PDEA’s SGRS College of Pharmacy, SaswadPDEA’s SGRS College of Pharmacy, Saswad
PRESENTATION
ON
DIRECTLY COMPRESSIBLE VEHICLE
PRESENTED BY: Mr. Vishal Dattatraya Shelke.
M.Pharm Sem - I
GUIDED BY : Mrs. S.S Mutha
DEPARTMENT OF PHARMACEUTICS
2. CONTENTS
2
Introduction of Directly Compressible Vehicle
Requirements for Good DCV
What is Direct Compression ?
• Advantages
• Disadvantages
Classification of DCV
References
3. DIRECTLY COMPRESSIBLE VEHICLE
Introduction
These are the diluents or fillers designed to make up the required bulk
of the tablets.
These are inactive ingredients that are added to tablets in addition to the
active drug.
Some very common diluents in tablets include lactose and their
derivatives, starch, cellulose derivatives.
Used in the direct compression of the tablets.
3
4. Requirements For A Good DCV :
Non-toxic and acceptable to the regulatory agencies.
Low cost.
Physiologically inert.
Must be color-compatible
Stability.
Controlled particle size.
Good flowability.
4
5. What is Direct compression
Direct compression (DC) is the tabletting of a blend of ingredients i.e. the
compression mix, without a preliminary granulation or aggregation
process.
The compression mix contains the active pharmaceutical ingredient (API)
blended with one or more excipients.
The excipients may include binders, fillers/diluents, disintegrant and
lubricants.
5
6. Advantages of DC :
More Economic compare to wet granulation since it requires fewer unit
operations.
Documentation and validation requirements are reduced.
It requires less equipment, and space, time.
lower power consumpation , and less labor leading to reduce production cost
of tablets.
More suitable for moisture and heat sensitive APIs, since it eliminates
wetting and drying steps.
Lower microbial contamination
Faster drug release.
6
7. Disadvantages of DC :
Segregation because of the difference in the density of the API and excipients.
The dry state of the material during mixing may induce static charge and lead
to segregation. due to this problems like weight variation and content
uniformity may occur.
APIs that have poor flow properties and low bulk density is difficult to
process by direct compression.
DC excipients are costly because these are prepared by spray drying, fluid bed
drying, roller drying or co-crystallization.
7
8. Classification of DCV:
Disintegrants And Poor Flow:
ex. Microcrystalline cellulose , Starch .
Free-flowing Materials That Do Not Disintegrate :
ex. Dicalcium phosphate dihydrate.
Free-flowing Powders That Disintegrate By Dissolution:
ex. Lactoses,Sucrose, Dextrose
Sorbitol , Mannitol
Co-processed exicipients :
ex. Ludipress
8
9. Disintegrants And Poor Flow:
Microcrystalline cellulose:
It is a purified, partially depolymerized cellulose, which is prepared by
treating a-cellulose with mineral acids, producing bundles of needle-like
microcrystals.
It is White crystalline powder, odourless & tasteless
most useful filler for direct compression.
the compactibility of microcrystalline cellulose decreased with a reduction in
its moisture content.
9
10. Disintegrants And Poor Flow:
Starch :
Good compactability .
Starch -1500 :it is a form of pregelatinized starch that has been modified to make it
more compressible and flowable in character.
Useful as a result of their good binding and disintegrant properties
High moisture content 12-13%.
Accelerate the decomposition of moisture sensitive drugs.
10
11. Free-flowing Materials That Do Not Disintegrate:
Dicalcium phosphate dihydrate:
Filler produced by A complicated process using phosphoric acid and slaked
lime.
low cost and desirable flow .
Used in vitamin and mineral supplements because of the high calcium and
phosphorus content.
Rapidly and completely penetrated by the liquid
11
12. Free-flowing Powders That Disintegrate By Dissolution:
Lactose :
Natural disaccharide - 4.6% of cow’s milk.
Lactose present in different polymorphs depending on the crystallization
conditions. i.e a and b lactose .
Most popular as a tablet filler .
Lactose derivatives :
a-lactose monohydrate:-
It is hard crystal. Non hygroscopic.
Excellent physical and chemical stability.
Good water solubility. Poor binding property. Good flowability
12
13. Free-flowing Powders That Disintegrate By Dissolution
Sucrose:-
Used as a filler in tablets.
Used as co-crystallized sucrose with 3% modified dextrin.
Good flow properties.
Need glidant only above 50% relative humidity.
Excellent color stability.
13
14. Dextrose :-
It is crystallized dextrose contains 3-5% maltose.
Moisture content 9%. Available in both anhydrous and hydrous product.
Highly compatible.
At 75% relative humidity it becomes quite hygroscopic.
Good flowability, & filler-binder
14
Free-flowing Powders That Disintegrate By Dissolution:
15. Free-flowing Powders That Disintegrate By Dissolution
Sorbitol :
Affect the compactability and stability.
Moisture content 0.5-2%.
Mostly used in chewable tablets.
It has cool taste so used in ‘sugar free’ mints.
It is hygroscopic
Need of lubricant when moisture content exceeds 2% in formulation.
15
16. Free-flowing Powders That Disintegrate By Dissolution
Mannitol :-
It is used where complete solubility is required.
It is costly. Used as A filler in chewable tablets.
It is non-hygroscopic.
It also has cooling mouth feel.
Maltodextrin :-
It is highly compactible.
Completely soluble.
Low hygroscopicity.
16
17. Co-processed exicipients:
Ludipress :
It consisting of three components:a filler, a binder and a disintegrant.
The exact concentrations of its constituents are stated below:
93.4% a-lactose monohydrate,
3.2% polyvinyl pyrrolidone and
3.4% crospovidone.
Excellent flowability.
17
18. REFERENCES -
Pharmaceutical dosage forms tablet Vol-II second edition lachman leon,
lieberman H.A. Page.No 77-160.
www.authorstream.com
18
19. Also available on Youtube!
Youtube :- https://youtube.com/vishalshelke99
Instagram :- https://instagram.com/vishal_stagram