English for Pharmaceutical Equipment and Technology

Unit 1 Tablet and Capsule Manufacture Capsule Filling

Tableting Machine Machine

Pharmaceutical dosage form

Solid Dosage Form
Tablet

Liquid Dosage Form

Capsule

Powder

Unit Dose Operations

Concepts
Unit Operation Every separate manufacturing step. Unit Dose Operations Determined by what manufacturing steps are needed to combine the active ingredient with other needed ingredients to make a quality finished product.

Unit Dose Operations of Solid Dosage Form

Crystallization /drying

Milling

Blending

Granulation

Compression

Coating

Packaging

Crystallization
Crystallization from solution is an industrially important unit operation due to its ability to provide high purity separations, which explains its predominant use in the pharmaceuticals industry.

Milling
Improve flow, reduce segregation, enhance drying, and limit wide particle size distribution

Blending
V-shaped Blender and Double-cone Blender

Blending
Barrel Blender and Bin Blender

Granulation
WHY GRANULATE?

To improve powder flow. To improve compressibility. To reduce fines. To control the tendency of powders to segregate To control density. To capture and fuse small quantities of active material.

Batch High Shear Mixer

Continuous Granulator

Compression
The ultimate test of a tablet formulation and granulation process is whether the granulation can be compressed on a high-speed tablet press. During compression, the tablet press performs the following functions: 1. Filling of empty die cavity with granulation. 2. Pre-compression of granulation (optional). 3. Compression of granules. 4. Ejection of the tablet from the die cavity and take-off of compressed tablet.

Different Punches &Dies

High Speed Rotary Machine

Coating
Once a good tablet is made, we often need to add a coating. The coating can serve many purposes; it makes the tablet stronger and tougher, improves taste, adds color, and makes the tablet easy to handle and package.

Packaging
Pharmaceutical tablet packaging including blister packs and child resistant lidding

Three Principle Methods

Reading the part Three Principle Methods of Developing Powders for Tablet Making Answer the following questions.

Questions
What are the three principle methods of developing powders for tablet making ? What are the differences between the three methods and how to select the method in tablet making ? What is the difference between granulation, granule and granulator?

Three Principle Methods

Direct Compression
Blending the dry powdered ingredients together, and then compressing into tablets.

Wet Granulating
A pharmaceutical glue called a binder is put into water or a solvent solution and is sprayed or metered into the powders.

Dry Granulating
Use mechanical force to densify and compact powders together which forms dry granules.

Direct Compression
Introduction
In early days, most of the tablets require granulation of the powdered Active Pharmaceutical Ingredient (API) and Excipients. At the availability of new excipients or modified form of old excipients and the invention of new tablet machinery or modification of old tablet machinery provides an ease in manufacturing of tablets by simple procedure of direct compression.

Among the techniques used to prepare tablets, direct compression is the most advanced technology. It involves only blending and compression. Thus offering advantage particularly in terms of speedy production. Because it requires fewer unit operations, less machinery, reduced number of personnel and considerably less processing time along with increased product stability.

Manufacturing steps for direct compression

Direct compression involves comparatively few steps: i) Milling of drug and excipients. ii) Mixing of drug and excipients. iii) Tablet compression.

Wet Granulation
Wet granulation is a process of using a liquid binder to lightly agglomerate the powder mixture. The amount of liquid has to be properly controlled, as over-wetting will cause the granules to be too hard and under-wetting will cause them to be too soft and friable. Aqueous solutions have the advantage of being safer to deal with than solvent-based systems but may not be suitable for drugs which are degraded by hydrolysis.

In this process, powder is fed to a product container and then moistened or sprayed with molten material in order to increase the cohesive forces. The liquid can be water or an organic solvent, if necessary with a binder. At the same time, the ingredients are mixed together

Product characteristics
Dust free Good flow behavior Easy to dose Good dispersibility Good solubility Highly suitable for making into tablets Compact structure Low hygroscopicity High bulk density Wide grain size distribution

Dry Granulation
Dry granulating, also called Slugging, Chilsonating or Roller compaction, involves the pressing of mixed powders into an object to be reground into a precise powder. This action increases particle density, improves powder flow and captures fines. Powders can be compacted using a tablet press; this is called Slugging. Once slugging is completed or powders are compacted on a Chilsonator or Roller Compactor, they are milled.

The Dry Granulating method is used over other technologies for one or more of the follow reasons
1. Granulate materials which are sensitive to heat and/or moisture. 2. Produce a uniform particle size range. 3. Improve flow properties. 4. Control dust. 5. Control bulk density. 6. Produce uniform blends. 7. Control particle hardness.

Process route for Tablet Manufacture

Direct Compression Dry Granulation Wet Granulation

Granule, Granulation and Granulator

Granule a tiny grain

Granulatio n
the act of forming something into granules or

Granulator

Thank You!