Apart from capsules, tablets is a popular oral dosage form, a reason you need to understand the tablet manufacturing process.

Knowledge on tablet manufacturing process is important for students studying pharmacy, physician or medical practitioners, tablet press manufacturers, among other professions.

The best part?

Today’s guide explores all the intricate details of tablet manufacturing process, from basics, to advanced stages.

By the end of this guide, you will become a tablet manufacturing expert.

Without further ado, let’s jump right in.

Basics of Tablet Manufacturing

Let us begin with the basic of tablet manufacturing such as the definition.

What is a Tablet?

Apart from capsules, tablets is a popular oral dosage form, a reason you need to understand the tablet manufacturing process. Knowledge on tablet manufacturing process is important for students studying pharmacy, physician or medical practitioners, tablet press manufacturers, among other professions. The best part? Today’s guide explores all the intricate details of tablet manufacturing process, from basics, to advanced stages. By the end of this guide, you will become a tablet manufacturing expert. Without further ado, let’s jump right in. Basics of Tablet Manufacturing Let us begin with the basic of tablet manufacturing such as the definition. What is a Tablet?

Tablets

A tablet is a solid dosage form that consists of suitable pharmaceutical excipients and active ingredients.

Tablets vary in terms of shape, size, weight, thickness, hardness, dissolution and disintegration characteristics among other key aspects.

You can classify the tablets under the manufacturing method such as molded tablets or compressed tablets.

Types of Tablets in Pharmaceutical Industry

There are many types of tablets that you will come across in your learning experience.

Swallowing tablets

Swallowing tablets – Photo courtesy: THE PHARMA SAGE

Here is a list of some of them:

  1. Compressed tablets –Thus type of tablet comes from the compression of powdered granular or crystalline active materials. It may also combine other excipients including binders, release polymers, Disintegrants, diluents, lubricants, colorants and flavors.
  2. Film coated tablets (fct)
  • Sugar coated tablets (sct)
  1. Enteric coated tablets (ect)
  2. Multi-compressed tablets (mct) – You will make these tablets by passing them through more than one cycle of compression.
  3. Effervescent tablets
  • Chewable tablets
  • Sustained release tablets
  1. Dispersible tablets
  2. Multilayer tablets
  3. Troches
  • Sublingual Tablets
  • Hypodermic Tablets
  • Solution Tablets
  1. Implant tablets
  • Vaginal Tablets
  • Buccal tablets
  • Tablet triturates or Molded tablets

You can make this tablet from moist materials by using a mold that will giving them a cut section shape. They must be rapidly and completely soluble.

  • Dispensing tablets

Provide the most convenient quality of the potent drug that you can easily incorporate into a powder or liquid.

  1. Hypodermic tablets (Soft and readily soluble tablets for oral administration)

Long list, huh?

Let us look at some of the advantages and disadvantages of tablet dosage forms.

Advantages of Tablet Dosage Form

Using tablets come with their own set of advantages. You can classify the advantages under the user or production aspect of the tablet.

Tablet dosage form

Tablet dosage form – Photo courtesy: Pharmacy Tech Test

Production Aspect

  • You can produce a large scale of drugs at very low costs
  • It is easy and cheap to package the tablets and ship them
  • Tablets are very stable

User Aspect (Pharmacist, Doctor, Patient)

  • Handling the tablets is an easy process
  • It is compact and very light
  • It has great dose precision
  • The content variability is also very low
  • Tablets may provide the easiest mode of swallowing as they do not hang up above the stomach.
  • Tablets lend themselves to particular release products such as delayed release products or enteric.
  • Tablets have a good combination of properties including microbiological, mechanical and chemical stability of every oral form.

Disadvantages of Tablet Dosage Form

Tablets in blister pack

Tablets in blister pack

  1. Some of the drugs do not allow compression into denser compacts
  2. A drug with slow dissolution, poor wetting, large to intermediate dosages pose a great challenge in formulation. It is also impossible or difficult this type of drug into a tablet that will provide adequate drug bioavailability.
  • Some drugs have bitter tastes, and objectionable odor is very unpleasant for you to swallow. Others react with moisture and oxygen thus altering the efficacy. In these cases, further processes of encapsulation or entrapment are important.

With that in mind, let us proceed to the factors that affect the formulation process of the tablets.

Factors Affecting Tablet Formulation Process

Generally, your choice of formulation process will depend on certain factors such as:

Tablets formulation process

Tablets formulation process

        i. Active Pharmaceutical Ingredients (API) or Drug Substance Compression Properties

Different drug substances or active pharmaceutical ingredients have different compression properties. You may choose a formulation process that does not ogre well with the active ingredients.

You have to perform prior research on the active ingredients and their compatibility to different formulation process.

      ii. Chemical and Physical Stability of the API During the Tablet Compression

Formulation processes may affect and alter the physical and chemical stability of the active pharmaceutical ingredient.

You should, therefore, be very careful when you are selecting the type of formulation process.

Make sure that the integrity of the active pharmaceutical ingredient is not lost in the formulation process.

    iii. Size of the Particles of the Formulation Ingredients.

You need to look at the size of the active pharmaceutical ingredient before choosing the formulation process. Certain formulation processes can only accommodate specific particle sizes.

The formulation process may require very small particles or larger particles for active formulation.

     iv. Availability of the Processing Equipment

When you are choosing a formulation process, make sure that you have the necessary processing equipment. You may decide on a formulation process but the machine you have may not be compatible.

       v. Cost of the Formulation or Manufacturing Process

Your budget plays a huge role in the type of formulation process you intend to use. A low budget may not afford you the luxury of an efficient formulation process.

You have to make sure that you have all the necessary funds for a particular formulation process.

Are we getting somewhere?

You are yet to learn more about the tablet manufacturing machine in the next section.

Tablet Manufacturing Machines

Since there are numerous types of tablets in the market, you should expect to have different types of machines.

Why?

Different tablets require different formulation and manufacturing processes.

Implying that, you will need different types of machines to make the different types of tablets.

In this section, you are going to learn about the different types of machines available in the market.

Common machines that you will use in manufacturing pharmaceutical tablets include:

· Size Reduction Equipment such as Hammer Mill, Roller Mill, etc.

The size reduction equipment is a very important manufacturing equipment in the manufacture of tablets.

When you are manufacturing a compressed tablet, the process becomes simpler when the particles are of a certain size. It provides a greater and more uniform dose.

Fine particle sizes are essential in cases of lubricant mixing with granules for proper functions.

Apart from improving the biological availability of a medications or active pharmaceutical ingredient (API). The equipment is important for other functions such as:

  1. Reduction of sensitivity in case of over compensation
  2. To improve the quality of the tablet

The range of equipment that you can use for sizing include the fluid energy mill, colloidal mill and ball mill. Others are the harmer mill, roller mill, cutting mill, and conical mill.

For example:

A hammer mill will use “in air” mechanical impact force in the transformation of bulky material to smaller uniform particles. The key variable that the machine uses in controlling size of the particles include screen size and rotor speed. Feed throat and geometry will also play a major role.

· Wet Granulation Equipment

Following the reduction of sizes, you may need to granulate the formulation.

Wet granulation will provide the mix homogeneity of the distribution of drugs in the blend.

Wet granulation process

Wet granulation process

The sensitivity of this process requires you to have a good wet granulation equipment. Some of the machines you will use include:

  1. Rotating shape granulators
  2. Mechanical agitator granulators such as paddle or ribbon blender, planetary mixer, orbiting screw mixers or sigma blade mixer.
  • High shear granulators
  1. Fluidized bed granulators

Fluidized bed granulator

Fluidized bed granulator

· Dry Granulation Equipment

Dry granulation is a process where granule formulation does not require any liquids. The formation of the dry granules will require densification of dry powders for agglomeration.

The dry granulation machine depends on certain factors to produce the right size of particles. Some of the factors are roller speed, roll design, feed rate, particle size, die diameter and tooling features among others.

The machine has sub classes which you can distinguish by the force of densification application mechanism. The subclasses are slugging and roller compaction.

You will use the dry granulation equipment when:

  1. The drug does not compress properly after wet granulation
  2. You are granulating moisture sensitive drugs such as aspirin
  • You are granulating thermolabile drugs.

The advantages of using the dry granulators include:

  1. It covers very small floor space
  2. It is easy to clean the machine after using it
  • You can use the roller compactor for batch production and hard continuous operations
  1. It also eliminates any addition of heat and moisture
  2. It provides the tablet with uniform mechanical strength
  3. The operating and running cost of the equipment is low
  • It does not require you to include a binding solution.

The disadvantages of the dry granulators are:

  1. Does not have uniform distribution of color
  2. It creates and eliminates a lot of dust
  • There is the potential for cross contamination of the ingredients.

Drying Equipment such as Fluid Bed Dryer

You need to have a drying equipment to assist in drying the tablets. Some examples of drying equipment are rotary dryers, spray dryers, and fluidized bed dryers.

Let’s have a look at the fluidized bed dryer.

FBD

FBD

A fluidized bed dryer is an equipment that you can use extensively the moisture content in a tablet. It depends on the principle of fluidization of feed materials.

The process involves introduction of hot air at very high temperatures through perforated beds of the moist tablets. As the air passes, it lifts and suspends the wet tablets.

The direct contact between the hot gasses and the wet tablets results into a heat transfer. In the process it carries away the liquid from the tablets leaving it dry.

To save energy, you may need to partially recycle the exit gas.

Advantages of the fluidized bed include:

  1. Very high rate of moisture removal
  2. High thermal efficiency
  • Low cost of purchasing and maintaining
  1. Easy to control as the contact time for drying is minimal

The disadvantages include:

  1. Higher energy consumption due to high pressure drops
  2. Requires a complete gas handling process
  • Low flexibility and poor fluidization
  1. High potential of attrition and agglomeration
  2. It is more compatible to drying fine particles

· Mixing Equipment, such as Mixer Machines e.g. Drum blender, Ribbon Mixer, etc.

You will also need a mixing equipment to mix the active pharmaceutical ingredients of the tablet.

Ribbon mixer

Ribbon mixer

The different types of mixers include:

  1. Pneumatic mixers such as air drive mixers or air mixers
  2. Tumbling or diffusion mixers such as double cone blender, V-blender, cubic mixer, and drum blender.
  • Convective mixers including ribbon blenders, horizontal high-intensity blenders, orbiting screw mixers, planetary blenders, diffusion mixers, and Forsberg blenders.

We will briefly have a look at pneumatic mixers as an example.

You may identify it as air drive mixers or air mixers.

Instead of electricity, the mixer uses air bubbles or air compression for mixing or homogenizing or mixing powders. It has a mixing silo and a central conveying tube for spreading and mixing materials. It also has a housing cone with aerators around it.

Compressed air passes through nozzles and into silo. It mixes the active pharmaceutical ingredients especially those with expansion characteristics.

Advantages of using the pneumatic mixers include:

  1. Minimal risk of failure through misapplication
  2. Easy and less costly to clean and maintain
  • It employs an extremely gentle blending and mixing process
  1. Your input is minimal as you will handle the materials less
  2. It is not sensitive to heat
  3. Unlimited supply of air since it is available everywhere

The disadvantages include:

  1. Compression of air requires better preparation and a constant speed of the pistons.
  2. The air is only economical at producing a certain amount of force
  • The machine is noisy as it releases the air through the exhaust

· Pharmaceutical Instruments

Manufacturing a tablet will also require you to spend some time in the lab.

You will, therefore, need pharmaceutical instrument for that purpose. Some of the pharmaceutical instruments are:

Figure 10 Pharmaceutical instrument

  1. Tablet testing equipment such as dissolution samplers
  2. Friability testers
  • Refractometers
  1. Powder handling equipment
  2. Freeze dryers
  3. Tablet hardness testers
  • Dissolution testers
  • Fluorometers
  1. Photoelectric flame photometers
  2. Melting point apparatus
  3. Thermometers for measuring temperatures
  • Karl Fischer machine

You can use these machines for different purposes such as measuring the active pharmaceutical ingredients.

· Tablet Compression Machine

This is the machine that will assist you in compressing the ingredients to form a tablet.

There are two main types of tablet compression machines which are:

Pharmaceutical tablet compression machine

 

Pharmaceutical tablet compression machine

  1. Single punch tablet press
  2. Rotary or multi-station tablet press such as the multi-layer rotary and high speed rotary tablet machines.

Single Punch tablet press makes our example for this guide.

You can also identify it as the single station press or the eccentric press.

This machine employs one set of station tooling which is consisting of a die and a pair of lower and upper punches.

The force of compaction on the fill materials comes from the upper punch while the lower punch remains static. You can liken it to a single hammer punch thus the name stamping process.

The machine has the capability of producing between 60 and 85 tablets in a minute.

The advantages of the single punch tablet press include:

  1. The structure of the single punch is small and rational
  2. Operates at very high utilization ratio making it easy to operate
  • You can manufacture tablets with odd shapes with maximum diameters reaching 20mm
  1. It is ideal for small scale production of tablets
  2. It uses a lot of pressure to minimize variations in weight.

Apart from the machines in the above description, there are other important machines you should know. These include:

  1. Quality control equipment such as disintegration equipment
  2. Coating and polishing instruments such as perforated pan and standard coating pan
  • Packaging machines such as blister packaging machines and strip packing machines

Let us see some of the techniques that you will employ in the process of manufacturing tablets.

Techniques Used in Tablet Manufacturing Process

Tablet manufacturing requires a certain level of expertise to execute the job well. You need to have certain techniques at hand so that you can make good tablets.

It is also important to allow the drug mixture to flow freely from the tableting machine hopper to the dies. This will enable the compression of powder mix at very high speeds into tablets.

The most common techniques for tablet manufacturing that you should know are:

Wet Granulation in Tablet Compression Process

This is the method that you will employ when you want to produce compressed tablets.

This process of size enlargement goes through a series of processes. You also require an adhesive binder to complete the process.

The granules that you will get from this process includes all the physical properties you will need in a tablet.

Here are the steps that you need to follow during the wet granulation process.

Wet granulation process

Wet granulation process

· Step One: Weighing and Mixing

In this step, you will have to collect all the ingredients that you need. After that, you will have to weigh every active pharmaceutical ingredients using the pharmaceutical weighing equipment.

You will also measure specific quantities of the active pharmaceutical ingredients.

After that you will mix the ingredients together to form one uniform mixture of powders.

Note that at this stage you will not use any lubricants.

After that, the nest thing will be preparing the binder solution

· Step Two: Add Binder Solution

You will mix the binder solution from step two with the powders. You will get a solution in form of a damp mass.

· Step Three: Wet Screening

You will screen the damp powder into granules or pellets. You will employ the use of a 6 to 12 mesh screen to form the pellets.

· Step Four: Drying Moist Granules

At this stage, you can use the different types of dryers in your possession to dry the moist granules. Make sure that you eliminate any form of moisture in the granules.

You should have rates that will indicate that the drying process is standard.

· Step Five: Sizing Granulation

At this stage, you will need a 14 to 20 mesh screen to size the granules.

After that, thoroughly mix the dry granules with a disintegrant or lubricant.

Lastly, you will compress the granules to form tablets.

Wet granulation process will produce a tablet that has sufficient mechanical properties. You can go further and expose this tablet to other unit operations such as film coating.

Advantages of wet granulation manufacturing method

  1. It modifies all the properties of the formulation ingredients and overcome the deficiencies of tableting. The granules you will get are more spherical and exhibit better rates of flow.
  2. The compressibility of powders is better and you can employ low pressure during the compression process.
  • It uses conventional excipients and you don’t have to depend on excipients of special grades.
  1. The content of the tablets is uniform especially for the drugs that are soluble of low dosage.
  2. The process improves the dissolution rate of drugs that are poorly soluble. It will impart hydrophilic properties to the granular surface.
  3. The process will prevent segregation of the homogenous powder mix components. You can experience this during the processing, transferring, storage and handling processes. It also leads to a reduction in inter and intra batch variability.
  • It also reduces the high level of dust presence during the process of manufacturing. This reduces the possibility of cross contamination and health risk to the operators.
  • Air entrapment is very low thus compressibility of the drugs is higher.

The disadvantages of the wet granulation process include:

  1. It goes through a number of processing steps
  2. The cost is also higher since you will spend a lot of labor, time, energy, space and equipment.
  • The process is unsuitable for moisture sensitive and thermolabile materials.
  1. Soluble dyes may migrate during the process of drying
  2. You may also lose some active pharmaceutical ingredients during the process. This occurs when you are transferring the materials from one unit to the next.
  3. As the materials you produce through wet granulation ages, it might lose the rate of dissolution.

Dry Granulation in Tablet Manufacturing Process

You can also identify this process as double compression or pre-compression.

It is a process of tablet size enlargement that improves the compression and flow characteristics of a tablet.

The formation of tablets using the dry granulation process involves two main methods. These are slugging techniques and roller compaction.

Dry granulation

Dry granulation

The processes are the same but it may give you different results.

Slugging Technique involves the compression of powder particles into large and flat tablets. You may use a tablet press or a rotary press. You will employ the use of a hammer mill to mill the resultant compact.

Roller compaction technique involves passing the ingredients through counter rotating rollers. The ingredients will consolidate and densify into a solid mass. Depending on the machine, you can get dense flakes or briquettes.

You will further mill, lubricate and size the compact materials to form tablets.

Let’s go through a step by step process of the dry granulation method.

· Step One: Weighing the Ingredients and the Formulation

You will measure and weigh appropriate quantities of the ingredients. Make sure that the active ingredients and the excipients are in a finely divided form.  If not, you have to reduce the size of the particles.

· Step Two: Mixing of Formulation Ingredients

You will mix all the ingredients in a powder mixer until you achieve a uniform mix of the powder. At this stage, you will add half amount of the lubricants to the process. It will enhance the process of powder flow in the slugging process and prevent sticking of compressed powders.

· Step Three: Compression of the Mixture to Form Slugs

In this stage you will compress the tablets into large flat pallets or tablets. This is the pre-compression process and the compacts that you will get are slugs. You might decide to use the roller compaction techniques or the slugging technique.

Remember that the pressure you will apply vary from one compression stage to the next.

· Step Four: Sieving and Milling of Slugs

You will use a hammer mill or any milling equipment to break the slugs.

After that, you will screen the mills and produce uniform granules.

Step Five: Mixing with lubricants and disintegrants

After the screening process, you will add the remaining extra-granular excipients and lubricants such as glidants and disintegrants.

You will gently mix the granulation and the lubricants to achieve uniform blends.

· Step Six: Compressing Granules to Form Tablets

In this stage, you will use the single or double rotary press to compress the tablets. Remember you have to fit them with the right dies and punches.

You can also coat the tablets if need be.

Advantages of dry granulation are:

  1. Requires smaller floor space and less equipment
  2. It gives more attention to moisture sensitive ingredients as it eliminates addition of moisture.
  • It is also suitable for materials that are sensitive to heat because there is no drying involved.
  1. It does not involve the alteration of the morphology off the drugs during the manufacturing process.
  2. You don’t need special excipients as you can use the normal grade excipients
  3. The disintegration time is shorter as the binders have minimal adhesive effects.
  • You can also scale the process from development to production very easily.
  • It also improves the blending of the tablet since it does not involve migration

The disadvantages of the dry granulation process include;

  1. You need to have heavy duty and special equipment for granulation
  2. It generates a lot of dust that may cause cross-contamination
  • It may have powder flow issues
  1. The tablets tend to be softer hence susceptible to breakages.

Direct Compression Method in Tablet Manufacturing

It is very possible to manufacture tablets without taking it through the granulation and other unit processes.

Tablet compression

Tablet compression – Photo courtesy: Research Gate

You can achieve this by simply mixing all the ingredients in a blender and compressing them into tablets.

This process is only possible when you have ingredients that will flow uniformly.

There are three main techniques that you can employ in the direct compression method. These include;

  • Direct compression technique by using the die feeders
  • Direct compression technique using dry binders
  • Direct compression techniques using direct compression excipients

The process involves the following stages.

Stage 0ne: Pre-milling the Formulation

You will have to collect all the active pharmaceutical ingredients and mill them. You will mill the active ingredients and the excipients.

Step Two: Mixing

You will the active pharmaceutical ingredients with the powder excipients. You will also add the lubricants at this stage.

You can either use a blender or a mixer depending on your choice of machine.

Step Three: Compression

Using the compression tool of choice, you will compress the mix of powders to form the tablets.

Advantages of Direct Compression technique

  • It goes through very processing steps thus fewer equipment. This reduces the cost of tablet manufacturing.
  • You can carry out the manufacturing of tablets without using heat and moisture. In such a case, you are sure of getting a stable product.
  • Some excipients pose disintegration properties such as microcrystalline cellulose.
  • The dissolution time for these tablets is faster.
  • The dissolution profile of the tablets is stable.
  • The pressure you will employ in making the tablets hard is less.
  • Lubrication process and powder mixing occur in the same vessel.

Disadvantages of direct compression technique are:

  • High dose drugs may be a problem if the ingredients are not easily compressible.
  • The choice of excipients is very strict since most ingredients do not have good binding properties
  • You may not be able to blend uniformly the low dosage drugs
  • The excipients in use are often more expensive than other tablet excipients.
  • The number of tablets that you can manufacture by direct compression are very few.
  • The blending process in direct compression is not stable as the mixture may un-blend
  • In some occasions, the active pharmaceutical ingredient may react with the excipients.
  • It includes a lot of tablet defects requiring sticking, lamination and capping.

Common Problems in Tablet Manufacturing Process

It will be very unusual to be consistent and perfect in making different batches of tablets.

You will realize that some of the products will begin with a defect and end up with defects in the long run.

Weight variation from one tablet to another may cause a great challenge in the manufacturing process. You should ensure that the weight issue is not a problem because it is the genesis of solving other defects.

Tablet compression process

Tablet compression process

Some of the common tablet defects are:

· Molting of Tablets

This is the unequal color distribution on the surface of the tablet. You are able to see dark and light surfaces in an unusual coloring of the drug.

Causes of Molting

  • Variations in the color of the ingredients that you are using.
  • Drugs may have different degradation natures and therefore different colors of degrading products.
  • The dye might migrate to the surface during the drying process. High temperatures can induce migration of the dye to the uppers surfaces.
  • There might also be uneven distribution of the adhesives thus resulting into precipitation.
  • Improper sizing thus enhancing uneven color distribution
  • Improper conditions in the stores

Remedy to Molting

  • You can use bright coloring agents that will mask the variations in colors.
  • Proper drying by having a reduction in the drying temperatures
  • Add the adhesives with color when it is still hot to avoid precipitation.
  • Incorporate the fine powder adhesives before adding granulating fluid.
  • Grind the ingredients to smaller particle sizes.
  • Change the binder or the solvent system.

Sticking of Tablets

This occurs in tablets that have very low melting points substances.  These substances lower the speed of lower and upper punch leads and weight variation of the tablets,

It results in the formation of chipping and rough surface tablets and development of materials on both punches.

Causes of Sticking

  • Presence of thee low melting point substances in the mixture or formula
  • Excess moisture in the granules

Remedy of Sticking

  • Complete or partial substitution of the components with low melting points with high melting point substances.
  • Properly drying the granules to eliminate the excess moisture
  • Properly selecting good binding agents

Weight Variation on the Granule Sizes and Uneven Size Distribution

The main causes are:

  • Improper blending of the granules
  • Lack of enough lubricants
  • Abnormal mixing of the excipients
  • Improper setting of the machines and operating the machine at high speeds.
  • Improper selection of the glidants
  • Improper drying resulting in the formation of tablets with different weights.
  • Proportion of the large to small granules influencing the capacity of die filling.
  • Using large granules to fill smaller die cavities.

To solve the issue of weight variation of the tablets, you will uniformly distribute the sizes of the ingredients.

Poor Flow

The main causes of poor flow include:

  • Improper designing of the hopper
  • Poor flow ability of the granules
  • Arching or bridging of the granules at th base of the hopper
  • Stratification or segregation of the particles by using flow promoting devices such as vibrators
  • Surge of the excess flow above the hopper

You can rectify these issues by:

  • Improving the flow by using glidants
  • Properly designing the hopper
  • Properly using the flow enhancing devices like the vibrator
  • Preparation of uniform shapes and sizes of the granules

Poor Mixing

The main causes of this problem include:

  • Improper mixing of the ingredients such as lubricants and glidants which are important ffor proper punching and flow.
  • Inadequate or insufficient mixing time

The remedy to this problem is proper mixing and maintaining adequate time. You will also use a suitable mixer.

Punch Variation

The main cause of this problem is unequal length of the lower punches that cause variation of granular volume in die.

You need to use proper tools with uniform and good sizes of the punch.

Picking

This is tablet material adherence from the tablet surface by a punch

Causes:

  • Debossing or embossing or engraving on the tips of the punch with alphabetical letters

Remedy:

  • Mae sure that you design the lettering to be as large as possible or increase the size of the tablet
  • Add colloidal silica as a polishing agent
  • Using more binders that will increase the cohesiveness of the granules and cause a decrease in adherence
  • Avoid using wet granules
  • Plate the punch face with chromium materials to obtain a smooth face.

Hardness Variation

It might be a result of;

  • Weight variation of the granules with dye
  • Having space between the upper and lower punches

You can sort the problem by using an anti-turning device

Technologies in Manufacture of Pharmaceutical Tablets

Manufacturing of tablets is becoming better with time.

There are better technological advancements coming up every time.

These technological advancements are making it easy for manufactures to produce tablets. The same advancements are also making it easier for the consumer to get suitable tablets.

The most recent trends in the formulation of tablets include:

Versatile Immediate Release Tablet Systems

Tablet press

Tablet press

This includes:

  1. Faster dissolution drug delivery system
  2. Orally dispersible or disintegrating tablets
  • Orally dispersible mini tablets
  1. Fast dissolving or mouth dissolving tablets
  2. Novel fixed dose combination tablets
  3. Conventional effervescent
  • Film coated and uncoated tablets

Patented Technologies for Fast Dissolving Tablets

Some of the most popular patented technologies include the following:

a) Zydis Technology

It is the best fast dissolving and disintegrating tablet preparation technology.

It involves making of tablets that will dissolve in your mouth as soon as you place it on the tongue. The Zydis tablets should take approximately 2 or 3 seconds to dissolve.

The techniques of making a Zydis tablets involve freeze drying or lyophilizing the drug in gelatin matrix.

Zydis products are lightweight and fragile and usually has a special blister pack. It is also self-preserving as the water in the tablet is too low to allow for microbial growth.

b) Durasolv Technology

This is a patent technology from CIMA labs.

The content of this type of technology produces a tablet with a drug, lubricant and fillers.

The equipment you will use for preparing these tablets are conventional and possess great rigidity.

It allows you to pack them in conventional packaging systems such as blisters.

It is the best form of technology for the products that require low amounts of active ingredients.

c) Orasolv Technology

This is another product from CIMA labs.

The active medicament in this technology has a taste mask. Apart from that, it also has effervescent disintegrating agent.

The process of making these tablets is direct compression but with minimal pressure. This will allow the tablet to disintegrate faster when you consume it.

The tablets are friable and soft with special pick and place designed packages.

d) Flash Dose Technology

This is a product from Fuisz.

Nurofenmeltet, which is a form of ibuprofen will definitely melt in your mouth. Manufacturers use the flash dose technology to prepare this tablet.

This technology produces tablets that consist of self-binding shear form matrix which you can identify as floss.

The shear form matrix involves flash het preparation methods.

e) Wowtab Technology

This is a product from Yamanouchi Pharmaceutical company.

WOW is an abbreviation that means without water.

It involves combing low mouldability saccharides and high mouldability saccharides. This process results into the formation of strong tablets that can melt rapidly.

The active pharmaceutical ingredient mixes with a low mouldability saccharide and the granulates with a high mouldability saccharide.

After that, you then compress it into a tablet.

f) Flashtab Technology

This is a product of prographam laboratories.

The active ingredient in this case are available in the form of micro-crystals.

In this case, you will use the conventional procedures to prepare the drug micro granules.

These procedures are micro encapsulation, coacervation, and extrusion spheronization.

All these processes undergo the conventional technology of tableting.

Another important aspect of tablet manufacturing is the packaging.

In the next section, we will briefly take you through the packaging process of the tablets.

Let’s find out.

 

Packaging Tablets in Pharmaceutical Industry

After completing the manufacturing process of the tablets, the next step is distributing them.

Before you distribute the tablets, you have to package them first using appropriate packaging material.

The type of packaging materials that you will use will depend on your personal choice. Apart from your choices, there are other factors that you need to consider including:

  • The degree of protection that a particular drug requires
  • Compatibility of the drug formulation to the packaging material
  • Presentation of the tablets especially to the tablets that have very high demand.
  • The convenience of the customer considering the weight, size and opening method. It also includes the closing legibility of the printing among others.
  • The method of filling the tablets
  • Cost of packaging the tablets

The most common methods that you may use in packaging the drugs include blister and bottle packaging. After that you will store them in a place with low humidity and cool temperatures.

Blister Packaging Tablets

This a universal term for preformed plastic packaging for pharmaceuticals such as tablets. The main components of the blister pack in the thermoformed plastic.

It has a primary packaging that will envelop the product and hold it in place. The main primary components of the blister packs are the cavity and the lidding.

Blister packing of tablets

Blister packing of tablets

 You will then cover it with a secondary packaging for grouping all primary packages in one place.

It also has a paperboard backing or an aluminum leading foil or plastic seal. You may also use a clamshell which is a type of blister that folds onto itself.

You will use the blister packages for unit packaging of doses.

Bottle Packaging of Tablets

This type of packaging is good for very strong tablets that cannot break easily. You will place the tablets in a bottle which is the primary package. After that, you will cover the bottle with a lid which acts as the secondary package.

Tablets in plastic bottles

Drugs in plastic bottle

After packaging the tablets in either the blister package or bottle package. You will place them in a tertiary package like boxes for bulk handling.

Let us proceed to the last section of this guide which covers the quality control tests.

Quality Control Tests for Tablets in Pharmaceutical Industry

Before you start marketing the tablets, you have to make sure that they are fit for human use.

You have to subject the tablets through a series of tests before releasing them to the public.

The tablets have to conform to the official conventional and compendium requirements of the pharmaceutical industry.

Tablet friability testing machine

Tablets friability testing machine

The series of tests fall under two main categories which are:

  • Pharmacopoeial or the official tests
  • Non- Pharmacopoeial or non-official tests

§ Pharmacopoeial or Official Test

The tests are official since the testing procedure is in the official compendia including the British Pharmacopoeia and American pharmacopoeia.

These are standard testing procedures that have clear limitations which dictates the levels a tablet should reach.

The quality tests include:

  1. Testing the content of the active ingredient or the absolute content of the drug
  2. Uniformity of the weight of the tablets
  • Uniformity of the content of the tablets
  1. Testing for the disintegration time of the tablet
  2. Testing for the dissolution of the tablet.

These tests focus on the content or in vitro release of the active ingredients. You must make sure that the content on the ingredient list should match the content of the tablets. Apart from that, the content of the tablets should conform to all the requirements of the official test.

§ Non- Pharmacopoeial or Non – Official Test

These are the tests that you will perform on the tablets even though they are not on the official compendia. It concerns a number of quality attributes that you have to evaluate including:

  1. The porosity of the tablets
  2. Crushing strength or hardness strength
  • Friability test
  1. Determination of tensile strength
  2. Thickness test

Most of these tests do not have an official testing limit for acceptance and vary from one manufacturer to another. It may also vary according to the formulation.

Even though the crushing strength limit was on the British Pharmacopoeia, it has no limits set to it.  it will, therefore, remain under the non-official test.

Quality tests of pharmaceutical tablets requires you to be extremely keen. Any defect might cause detrimental effects to the final consumer.

You have to perform these tests during the process of production.

After the production of every batch, you should also perform a verification test.

Conclusion

Well, I believe that your level of expertise in tablet manufacturing is a notch higher.

Your knowledge on manufacturing tablets should reassure you of the safety of the tablets you consume.

You can also start thinking about having your own manufacturing company.

Why not?

All you need is enough capital and the right qualifications and you are good to go.