Wednesday, December 30, 2020

Lubricants used in pharmaceutical industry

Lubricants are the most important excipients which are used for the manufacturing of oral solid dosage forms in pharmaceutical industries.Lubricants are used to reduce friction between machine parts and the product to make the process smooth.

If lubricants are not present in the formulation then sticking, picking like problems may occur and it results in decreased efficiency of the compression, encapsulation and dry powder filling machines. Coast of operation is also increased due to wastage of time, so a good lubricant is selected to overcome these problems.

In this article we will discuss working of lubricants,their effective concentration for use,types of lubricants either hydrophilic or hydrophobic,effect of over lubrication and importance of blending time with lubricants.

Mechanism of Lubricants

There are four mechanisms of lubrication

  • Hydrodynamics lubrication

  • Elastohydrodynamic lubrication

  • Mixed Lubrication

  • Boundary lubrication

First three are usually for liquid lubricants and forth one mechanism that is boundary lubrication is involved in the lubricants used for oral solid dosage forms.

Lubricants used for oral solid dosage form are in the form of fine powders. They form a layer around granules and reduce friction between machine parts and the product.


Characteristics of Good Lubricant.

A good lubricant usually has the following three main characteristics.

True Lubricant Role 

Lubricants having a true lubricant role reduce friction between die walls and tablets formed during ejection.

Glidant Effect

A good lubricant also has a glidant effect meaning it reduces friction between particles and increases flow.

Anti Adherent Effect

A good lubricant must have an anti-adherent effect meaning it should prevent sticking of the product to punch face in case of compression machine and to tamping pins in case of encapsulation machine.

Also Read: 


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Properties of a Good Lubricant.

  • It should be inert.

  • It should be effective in low concentration.

  • Should form a layer around granules to give a good lubricating effect.


Types of Lubricant

There are two types of lubricant 

  1. Hydrophobic Lubricants

  2. Hydrophilic Lubricants


  1. Hydrophobic Lubricants

  • Hydrophobic lubricants are insoluble in water.

  • Hydrophobic lubricants are lipophilic.

  • These are most commonly used lubricants because they are most effective to reduce sticking and picking.

  • They are effective in low concentration.

  • Hydrophobic lubricants have all three main characteristics meaning true lubricant role, anti-adherent and glidant effects.

  • The mixing time and concentration of Hydrophobic lubricants should be adjusted carefully.

  • Increased blending time or higher concentration of Hydrophobic lubricants results in following tablet defects

    • Prolonged Disintegration Time.

    • Retard Dissolution.

    • Reduce Compaction

    • orLow Hardness

    • Tablet capping


Prolonged Disintegration Time & Retard Dissolution.

When higher concentrations of hydrophobic lubricants are used or when blending time with hydrophobic lubricants is increased the covering formed around lubricant becomes strong and it repels water so disintegration time is increased and dissolution profile is decreased.


Reduce Compaction, Low Hardness & Tablet capping

When the coverings formed by hydrophobic lubricants becomes strong it results in slippery surfaces of granules due to lipophilic covering.It may results in decreased compaction properties because when we apply pressure to compress the granules or powders the surfaces slip and proper hardness is not achieved, this may also result in tablet capping.

Solution

  • Blending time with hydrophobic lubricants should not be prolonged.

  • It should be  3-5 minutes.

  • The concentration of hydrophobic lubricants should be optimum.


Also Read: 


Lux level for Different areas in pharma. 


Examples of Hydrophobic lubricants

Following are some main examples of hydrophobic lubricants.

Metal salts of Fatty Acids

These are as follow,

  • Magnesium Stearate

  • Calcium Stearate 

  • Zinc Stearate

In this category, Magnesium stearate is most important and is the most widely used lubricant.

Fatty Acid

It includes the following

  • Myristic Acid

  • Palmitic Acid

  • Stearic acid

Fatty Acid Esters

Inorganic Materials

It includes following 

  • Talc


Magnesium Stearate

Magnesium Stearate is a hydrophobic lubricant and is insoluble in water.

It is also known as die wall lubricant and it is the most widely used lubricant in pharma industries for manufacturing of 

tablets,capsules, dry powder suspensions and sachets.

It is effective in low concentration.

Concentration of Magnesium Stearate

The recommended concentration of Mg stearate as the lubricant is 0.25-5%.

 (Ref Handbook of pharmaceutical excipients.)

Appearance

  • It is fine white powder with faint odour.

  •  It has low bulk density.

  •  It adheres to the skin.

  •  One common identification test for Mg stearate is that it fills the pores of fingers in a very fine and smooth way and it can not be removed or cleaned from pores by rubbing it.

Precautions for Mg Stearate

  • Always use a mask and gloves to use mg stearate. 

  • It may cause respiratory problems so always wear a mask.

Incompatibility

Mg Stearate is incompatible with following,

  • Strong Acid

  • Iron Salts

  • Alkalis

  • Aspirin

  • Few vitamins

It is also practically observed that we do not use the Mg stearate in the products containing aspirin and instead of Magnesium Stearate we use talc or talcum.

Talcum

  • Talc is also known as talcum.

  • It is a naturally occurring mineral.

  • It is insoluble in water and is a hydrophobic lubricant.

  • It is used in products where we can not use Mg stearate like in aspirin formulations.

Apart from using as a lubricant,talc is also used as 

  • Glidant

  • Diluent

  • Dusting powder

  • In Controlled release product to retard dissolution


Concentration of Talc


Role

Concentration

Lubricant

1.0-10%

Glidant

1.0-10%

Diluent for Tablets 

5-30%

Diluent for Capsules

5-30%

Dusting Powder 

90-99%


  Stearic Acid

  • It is used as a lubricant in tablets and capsules.

  • It is also used as a binder.

  • It is insoluble in water.


Concentrations of Stearic Acid

It is used as lubricant in tablet in concentration of 1-3%

Palmitic Acid

  • Palmitic acid is used as a lubricant for manufacturing of tablets and capsules.

  • It is insoluble in water.

Myristic Acid

  • Myristic acid is used as a lubricant for manufacturing of tablets and capsules.

  • It is insoluble in water.


  1. Hydrophilic Lubricants

  • Hydrophilic lubricants are water-loving.

  • Hydrophilic lubricants are not as good lubricants as hydrophobic lubricants.

  • They do not possess an anti-adherent and glidant effect.

  • The layer formed by hydrophilic lubricants is not too strong so it does not affect the disintegration and dissolution profile of the product.


Examples of Hydrophilic Lubricants

Following are some examples of hydrophilic lubricants

  • Sodium Stearyl Fumarate

  • Sodium Lauryl Sulphate

  • Magnesium lauryl sulphate

  • Sodium Benzoate

  • Polyethylene Glycol


Sodium Stearyl Fumarate

  • Sodium stearyl fumarate is less hydrophobic lubricant.

  • Layers formed by Sodium stearyl fumarate do not affect product disintegration and dissolution profile.

  • Sodium stearyl fumarate is used as a lubricant during manufacturing of  tablets and capsules.

Concentration of Sodium Stearyl Fumarate

It is used as a lubricant for tablet and capsules in a concentration of 0.5-2.0%


Sodium Lauryl Sulphate

  • Sodium lauryl sulphate is commonly known as SLS.

  • It is a surfactant and is used as a tablet and capsule lubricant.

  • It should be used with great care because it may cause irritation to the following,

    • Skin

    • Eyes

    • Respiratory Tract

    • Stomach

Concentration of SLS

SLS is used as a lubricant in concentration of  1-2%.


Sodium Benzoate

  • It is a water soluble lubricant.

  • Sodium benzoate is used as a lubricant for manufacturing of tablets and capsules.


Polyethylene Glycol

  • It has different grades.

  • It is water-soluble.

  • it is used as a lubricant.


Advantages of Lubricant

  • Lubricants eliminate sticking and picking.

  • Lubricants make the compression process smooth.

  • Lubricants make the encapsulation process smooth.

  • Make sachet or dry powder filling operations smooth.

  • Reduce the cost of operation due to a smooth process.

  • Enhance machine efficiency.

  • Save time.


Important Note:

  • Lubricants are more effective when their surface area is increased.

  • Sieving of lubricants increases their surface area.

  • Always use lubricants after sieving.

  • Do not mix lubricants with other excipients for sieving.

  • Do not mix lubricants with other excipients for blending.

  • Add lubricants at the end, when blending with all other excipients is completed.

  • Blending time should be minimum.


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Sunday, December 27, 2020

Coronavirus prevention in pharmaceutical industries.

The first case of Coronavirus was detected in December 2019 and later on in a short period, coronavirus spread all over the world and become pandemic.

Up till now coronavirus is still spreading and affecting more and more people around the globe.

Coronavirus disturbed all the working routines and it changed the way people work. Many new concepts were introduced like social distancing, work from home etc.

Almost one year of this pandemic is completed but still, no vaccines are commercially available for common people of the word.

On December 2, 2020, the United Kingdom became the first country who approved the vaccine of a pharmaceutical company named Pfizer.



On 8 December 2020, a 90-year-old patient was given the first dose of vaccine.

In the first stage, it will only be given to the

  • Health care staff

  • Old age people

Many other Vaccines are under trials and even if these trials are successful it is not possible to vaccinate all the people of the world immediately. So it will take more time to develop a proper treatment for this pandemic.

The best practice to prevent the attack of coronavirus is to keep yourself safe at home or work by adopting safety measures.

The concept of Stay at Home and Work from Home is not possible for all workers, especially for those who are working in hospitals and pharmaceutical industries.

In this article, we will discuss mainly the safety measures which should be taken by the pharmaceutical industries for the prevention of coronavirus.

So the question is what preventative measures a pharmaceutical industry should take to keep their staff safe during work at a manufacturing plant?

Following are some measures which a pharmaceutical industry must take to safeguard the working staff.

  1. Segregation of Staff

  2. Health Monitoring Team

  3. Training

Training may be on the following,

  • Social Distancing

  • Hand washing

  • Use of sanitiser

  • Use of Mask & Gloves

  • On work precautions

  1. Monitoring of Visitors

  2. Monitoring of vehicles

  3. General Instructions


  1. Segregation of Staff

The first step which a pharmaceutical industry should take is to categorise the staff based on their engagement to the work. For this, staff can be divided into following 

  • Essential Staff

  • Non-Essential Staff

Essential Staff

  • Essential staff is the staff of the pharmaceutical industries which is physically required on the floor of the manufacturing plant and their involvement is essential for performing tasks in the pharmaceutical industries.

  • Presence of Essential people is always required in the pharmaceutical manufacturing plant and they can not perform their duties from home. 

  • So the concept of work from home is not suitable for them.

Example

Some key examples of essential staff are given below(There may be many more,)

  • Pharmacists

  • Working staff for

    • Manufacturing

    • Packaging

    • In-process control

    • Quality Control 

    • Raw material store 

    • Security

    • Canteen

    • Housekeeping

    • Engineering Staff


Also Read:

Role of pharmacist on the production floor.


Non-Essential 

  • Non-essential staff in the pharmaceutical industries are the people who can perform their duties from home and can communicate in the manufacturing plant using online platforms.

  • It includes many supporting departments like Human resource, finance, planning etc.


  1.  Health Monitoring Team

  • The Human Resource department of every pharmaceutical industry should establish a Health monitoring team which should check all the staff on a regular basis.

  • A qualified doctor should also be part of this team and should be available during working hours.

  •  Any person having symptoms of severe cough,  flu,  fever etc should be examined by the Doctor and if found to be infected should be isolated in a separate area.

Immediate Actions

  • If an infected person is found, separate him immediately.

  • Immediately disinfect the area where he was working.

  • Separate the persons who were engaged with the infected person and diagnosed them.

Health monitoring team should prepare a health form to collect the health data of all the employees and their family.


  1. Training

  • Most effective awareness about coronavirus prevention can be delivered through training.

  •  Training can educate the staff or people to keep themselves and their families safe.

Following training may be beneficial in the pharmaceutical industries.


Work From Home

  • Pharmaceutical industries should try to minimise the presence of working staff in the manufacturing plant.

  • Essential staff can not perform their jobs from home but non-essential staff can perform their duties from home.

  • So the non-essential staff should be trained to work from home.

  • Work from home is the concept of working online from home.



  • Different software and applications are used to complete the office work from home

  • Staff should be properly trained to perform their duties from home using this software and applications.

  • It will minimise the chances of contact with others and results in a reduction of people gathering.


Social Distancing

  • All the staff or people present in the pharmaceutical industry should be aware of the concept of social distancing.

  • People should be educated and trained through visual aids.

  • Concept of Social distancing minimises the chances of exposure and being infected.

  • 2 meter or 6 feet is considered a safe distance.

  • The reason behind 2 meters is that usually sneezing droplets settle down within 2 meters.



  • Avoid physical contact and be at a distance of 2 meters.

  • In the break, hours discourage the gathering of staff.

  • Define different lunch and dinner breaks timings for different departments.

  • In lunch and dinner breaks try to utilize the outdoor facility.

  • Minimise the setting of chairs around the dining tables.

  • Increase the distance between the dining tables.

  • Place labels on the floor at different gathering points at a distance of 2 meters or 6 feet and educate people to stand on these labels.

  • This type of marking ensures the maintenance of the exact distance.



Hand washing

  • Pharmaceutical industries should educate their staff to wash hands regularly.

  • The recommended procedure for washing hands is as follow  

    • Make your hands wet with water.

    • Apply some soap.

    • Rub your hands with soap for 20 seconds.

    • Again pour water on soapy hands and rinse thoroughly.

    • Dry your hands.

  • Rubbing with soap breaks the lipid layer of the virus and removes them.

  • Wash Basin and soap stations should be installed at different places within the boundaries of the pharmaceutical industry.

  • It will reduce the gathering of people and will prevent the chances of contamination.


Also Read:

How to prevent microbial growth in purified water.



Use of sanitiser

  • All the working staff and people in the pharmaceutical industries should be educated to sanitize their hands after regular time intervals.

  • Hand Sanitisers should be installed at different places so that it should easily be accessible to the people.

  • For sanitization simply 70% IPA solution can be used.


Also Read:

How to prepare 70% IPA.




  • Pharmaceutical industries should install walkthrough sanitiser chambers at different places like the main entrance,  canteen entrance etc.

  • Pharmaceutical industries should establish a sanitization team to sanitize all the Commonly used areas regularly.


Use of Mask & Gloves

  • All the working staff should be educated about the importance of wearing masks and gloves.

  • Instructions should be displayed in writing at different places to wear masks and gloves.

  • A monitoring team should be established to check the usage of masks and gloves.

  • People should be trained about the disposal of masks and gloves after usage.

  • Educate the people not to touch their eyes, nose and face while having gloves.



During the work precautions.

 During manufacturing and packaging operations in pharmaceutical industries, it may not be possible to keep the social distance of 2 meters or 6 feet so it is advised to take following protective measures,

  • Wear a mask and gloves.

  • Wear secondary gowning

  • Wear protective shields.

  • Try to avoid physical contact with each other.

  • The temperature of the staff should be monitored at regular intervals with a temperature scanning gun.

  • Before starting the work disinfect the floor and workplace and repeat the same practice during work after defined intervals.

  • If dealing with objects receiving from outside try to disinfect it if possible.

  • Material transfer trolleys etc should be disinfected before use.

  • Working staff should be reduced by rotating the duties.

  • Divide the working hours into various shifts to minimise the chances of rush.


  1. Monitoring of Visitors

  • Pharmaceutical industries should try to minimise the number of visitors.

  • If any visitor comes, try to deal with the online video linking system.

  •  For this allocates a visitors room near to the main entrance.

  • Instruct the visitors to use the walk-through sanitising chamber.

  • Check their body temperature by a temperature scanning gun.

  • Provide them masks and gloves.

  • Disinfect the visitor's room after the regular time interval.


  1. Monitoring of vehicles

  • Any vehicle coming from outside to the pharmaceutical industry should be sanitized to minimize the risk of contamination.

  • The driver of the vehicle should be asked to pass through a sanitizing chamber.


  • Disinfects all the indoor and outdoor areas regularly.

  • Do not share mobile phones.

  • Try to avoid the use of a finger to operate lifts.


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  1. General Instructions

  • Display different visual aids at different places to educate the people.

  • Do not use your hands to open the door, instead attach a foot handle to open the door with the foot.

  • Try to keep open the frequently used door. (Not for manufacturing classified rooms)

  • Disinfect the door handles regularly.



  • Disinfects all the indoor and outdoor areas regularly.

  • Do not share mobile phones.

  • Try to avoid the use of a finger to operate lifts.


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