An Overview of pellets

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Pellets are small spherical free flowing units with improved flow properties and flexibility in formulation development and manufacture. Their size and shape allow their administration as injections and also for oral drug delivery. Various methods of pelletization are balling, drug layering, extrusion-spheronization, spray drying, spray congealing are available. They can be used to design various customized release profiles. In this presentation, various applications and advantages of pellets were discussed along with their manufacturing methods especially drug layering and extrusion-spheronization Key words: Pellets, Extrusion-spheronization, Drug layering, coating

Profile link page of author: http://www.pharmainfo.net/sailesh
Profile link page of co-author: http://www.pharmainfo.net/tegkmurthy

 

Comments

G N S HEMA SREE's picture

hi , you have mentioned in the extrusion spheronization technique the polymer can be applied either with drug or at last step as barrier coat. Does it have any effect in drug release pattern if so in what way and which releases the drug fast.

G.N.S.Hemasree

G.Sailesh's picture

Thank you for your query. If the polymer is taken along with drug in extrusion-spheronization, it gets embeded in polymer matrix similar to our microsphere. Otherwise, polymer can be coated on the pellet similar to our microcapsule. Definitely, it will have effect on the release mechanism and drug release profile that in turn depends upon the concentration and nature of polymer taken and of course the nature of drug.
SS Md Shafi's picture

COULD you please tell me about the formation of spherical shaped pellets..??

shafi ..

G N S HEMA SREE's picture

thank you for your reply, and what is the need of non-paeril seed cant we apply seal coat directly on the drug and additives instead applying drug non- paeril seed.

G.N.S.Hemasree

G.Sailesh's picture

Do you think Is it possible to construct a wall without a brick only with cement and sand and apply paint on it? Similarly it is not possible to coat a small individual drug particle in a coating pan uniformly
Abhishek Rathi's picture

Dear G. Sailesh, As we know pelletization is preferred over other coating method, but it has several things to monitored and manage starting from process to equipment variables. I wanna know which are the Process Analytical Technology variables monitored under this? Reagrds

Abhishek Rathi

G.Sailesh's picture

Pelletization is different from coating. Formation of pellets is pelletization which can be done by extrusion-spheronization, drug layering, balling, spray congealing. Coating can be done on pellets. "Process analytical technology(PAT)" is a part of Quality by design(Qbd) initiated by FDA which says that quality is to be built into product rather than testing it. It literally means control of various critical variables that are likely to effect the final quality by real time monitoring. For example, if we consider the coating process, critical variables are coating thickness, diameter, agglomeration that has to be monitored and controlled during the process itself. In pelletization (extrusion-spheronization)polymorphic changes, hydrate formation are some of the variables that must be considered during each and every step like blending, granulation, extrusion, spheronization. Various spectroscopic, digital imaging techniques help in achieving the objective of PAT. REFERENCES: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati... Mozina M, Tomazevic D, Leben S, Pernus F, Likar B. Digital imaging as a process analytical technology tool for fluid-bed pellet coating process. Eur J Pharm Sci. 2010 Sep 11;41(1):156-62. Epub 2010 Jun 9. Perez-Ramos JD, Findlay WP, Peck G, Morris KR. Quantitative Analysis of Film Coating in a Pan Coater Based on In-Line Sensor Measurements. AAPS PharmSciTech. 2005; 6(1): E127-E136 Sandler N, Rantanen J, Heinamaki J, Romer M, Marvola M, Yliruusi J. Pellet Manufacturing by Extrusion-Spheronization Using Process Analytical Technology. AAPS PharmSciTech. 2005; 6(2): E174-E183.
Abhishek Rathi's picture

Thanks for the Answer

Abhishek Rathi

Sudha Thamarapalli's picture

hello.. Could you please explain how particle-particle and particle-equipment collisions lead to the formation of spherical shaped pellets. Regards, Sudha.T

Regards,

Sudha.T

G.Sailesh's picture

A rope like motion is created due to rapid movement of the disc tearing a part the extrudate into cylindrical segments. Collisons between the particles and wall makes the cylindrical segments into spheres. Ref: http://spheronizer.com/html/spheronization.html You can see video of how spheronizer works in the following link http://www.lcicorp.com/granulation/spheronizer_ind.html
Pooja Chowdary's picture

on what basis pellet coatin is done?

pooja

G.Sailesh's picture

Can you please ask your question more clearly so that I can answer it?
Sandeep Reddy's picture

hi nice presentation 1)can you give me evalation parameters of pellets?
G.Sailesh's picture

Pellet size is very important for absorption. Amount of drug on the pellet has to be determined. Moisture content of the pellets is important as more moisture may result in contamination.
G.Sailesh's picture

Some of the typical evaluation parameters are bulk density, size and texture analysis, hardness, amount of drug coated, drug release studies
Sandeep Reddy's picture

hi can you elobrate the evaluation parameters?
Arun Kumar Palle's picture

can you explain me the pelletization process?
G.Sailesh's picture

Process of making drugs into pellets(pelletization). Various techniques are extrusion-spheronization, drug layering on to NP seeds, balling, agitation, spray congealing, spray drying etc. Reduced dose dumping: releasing of drug at once called dose dumping. Main reason is due to failure of coating. In case of pellets, failure of coating on one pellet will not effect the release of drug preventing dose dumping.
Arun Kumar Palle's picture

Can you explain me the two lines in your presentation >Increased bioavailability >Less Intra and Inter individual variation in bioavailability
G.Sailesh's picture

All the questions raised by you were explained in my presentation (with voice). Anyways, increased bioavalibality is due to micro metre range of particles. Intra individual variation: Pellets have good flow properties and they behave is liquid. They can flow even if the pyloric sphincter is open or closed. So variation in bioavailability due to food effects is reduced. Similarly GI motility will have no effect on absorption of drug from pellets reducing inter individual variation (between two persons). Reduced local irritation: They will be in continous movement and there will be no accummulation at a particular region. So the irritation caused by irritant drugs is reduced.
Arun Kumar Palle's picture

Can you explain me about >Reduced local irritation >Prevents the risk of dose dumping
Pooja Chowdary's picture

on which basis pellet coating is done?

pooja

G.Sailesh's picture

Pellet coating is performed to achieve desired type of drug release i.e., delayed release, sustained or controlled release by selecting suitable polymer at required coating level.
Harsh bansal's picture

hello sailesh nice presentation i have a simple question that is it any pron and con s of this tech. if yes how can we remove the cons ??? thank you

harsh bansal

G.Sailesh's picture

For extrusion spheronization: suitable for only high dose, have to optimize equipment related variables for both extruders and spheronizers, expensive. Drug layering: suitable to only low dose drugs, requires sophisticated equipment like fluidized bed coating to carry out the process effectively. It is difficult to compress pellets into tablets as it may damage coating. Sometimes, organic solvents have to be used as all the polymers may not be soluble in aqueous vehicle. Commercially, aqueous dispersions of water insoluble polymers are available (surelase, aquacoat- ethylcellulose dispersions).
Sirisha Pingali's picture

Is the process selected based on dose of the drug alone??

Sirisha Pingali

http://www.pharmainfo.net/sirisha

Viswanadha Institute of Pharmaceutical Sciences.

www.vnips.edu.in

G.Sailesh's picture

Not at all various factors like manufacturing cost, Nature of drug, polymer play an important role in selection of the process and technique
Pooja Chowdary's picture

can you explain me about thermal processing?

pooja

Pooja Chowdary's picture

What is meant by fluidised bed pelletization?

pooja

G.Sailesh's picture

Pelletization can be done on some fluidized bed coaters directly. Currently, fluidized bed coaters are being applied for coating of polymer over the drug pellets.
Pooja Chowdary's picture

What are the factors that effect the pellet quality?

pooja

G.Sailesh's picture

Pellet quality is influenced by number of variables like nature of starter seeds, type of technique employed, moisture content of starter seeds, nature of active ingredient, excipients used, equipment used etc.
Abhishek Rathi's picture

Dear Author, Could the Eutectic Mixtures be incorporated or converted into pellets? Could the liquification problem be solved by the pelletization?

Abhishek Rathi

Harsh bansal's picture

hello sailesh its last day today... its very nice to meet u through this competition your presentation is nice all the best for your future thank you harshbansal23@rocketmail.com harsh bansal

harsh bansal

Pooja Chowdary's picture

ALL THE BEST...

pooja

Abhishek Rathi's picture

Dear Author, All the best. Its been a very nice experience. It was a really awesome and knowledgeable. Thanks & Regards

Abhishek Rathi

Sandeep Reddy's picture

thanks for answering all the best
Arun Kumar Palle's picture

Dear Author Iam very much glad to meet you through this competition. And wish you all the best with regards Arun kumar palle & V.R.M.Gupta
SS Md Shafi's picture

HI... ALL THE BEST 2 ALL....

shafi ..

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