This document discusses the design and scale up considerations of pilot plants for tablet manufacturing. It begins by defining a pilot plant and its significance in transforming a lab-scale formula into a viable product. The objectives of the pilot plant include producing stable dosage forms, identifying critical process features, and providing information to support larger scale production. The document then discusses various unit operations involved in tablet manufacturing like material handling, blending, granulation, drying, milling, blending, compression, and coating. It provides details on equipment selection and process parameters that must be considered during scale up for each unit operation to ensure quality and reproducibility at production scale.
Pilot Plant:-
“Defined as a part of pharmaceutical industry where a lab scale formula is transformed into viable product by the development of liable practical procedure for manufacture”.
Scale-up:-
“The art of designing of prototype using the data obtained from the pilot plant model”
Pilot plant Techniques and Product consideration for liquid dosage forms.D.R. Chandravanshi
CONTENTS:-
DEFINITION
INTRODUCTION
OBJECTIVES
LIQUID DOSAGE FORM
STEPS INVOLVED IN PILOT PLANT FOR ORAL LIQUID
GENERAL CONSIDERATION
Reporting responsibility
Personal requirements
Space requirements
Review of formula
Raw materials
Relevant processing equipments
Process evaluation
GMP consideration
Assurance
PILOT PLANT SCALE UP FOR SUSPENSION
PILOT PLANT SCALE UP FOR EMULSION
REFERENCES
Pilot Plant:-
“Defined as a part of pharmaceutical industry where a lab scale formula is transformed into viable product by the development of liable practical procedure for manufacture”.
Scale-up:-
“The art of designing of prototype using the data obtained from the pilot plant model”
Pilot plant Techniques and Product consideration for liquid dosage forms.D.R. Chandravanshi
CONTENTS:-
DEFINITION
INTRODUCTION
OBJECTIVES
LIQUID DOSAGE FORM
STEPS INVOLVED IN PILOT PLANT FOR ORAL LIQUID
GENERAL CONSIDERATION
Reporting responsibility
Personal requirements
Space requirements
Review of formula
Raw materials
Relevant processing equipments
Process evaluation
GMP consideration
Assurance
PILOT PLANT SCALE UP FOR SUSPENSION
PILOT PLANT SCALE UP FOR EMULSION
REFERENCES
Technology Transfer in Pharma Industry, Technology Transfer in Pharmaceutical Industry, Pharmaceutical Technology Transfer, Pharma Tech Transfer, Naseeb basha, Pharmaceutical Tech Transfer, Naseeb basha Technology Transfer in Pharma Industry, Naseeb basha Pharmaceutical Technology Transfer
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
Video Lecture is available at https://www.youtube.com/watch?v=DXu_CLgB4q0
Introduction, terminology/definitions and rationale, advantages, disadvantages, selection of drug candidates. Approaches to design-controlled release formulations based on diffusion, dissolution and ion exchange principles. Physicochemical and
biological properties of drugs relevant to controlled release formulations.
It is the topic of Industrial pharmacy 2 from semester 7 of Bachelor of pharmacy.
It involved all information regarding Pharmaceuticals production scale up technique .role of managers, Engineer and scientists are explained properly .
ROLE OF MANAGER
1. Ensure a safe work environment for all pilot plant operations and compliance with all health and safety policies and procedures.
2.Provide technical leadership and operational oversight of Pilot Plant facility.
3.Partner with Process Development to optimize and implement new processes and technology at the pilot scale.
4.Train engineers and associates in the functional tasks necessary to successfully perform their duties.
5.Schedule activities of pilot plant personnel and ensure the tasks are completed in a timely manner.
6.Provide personnel career development, coaching, and feedback including performance management discussions with each direct report.
7.Train and oversee compliance with Quality Assurance policies and procedures that relate to the Pilot Plant.
8.Write and review standard operating procedures, batch records, process deviations reports, CAPAs, and change control requests.
Manage raw material receipt and release system.
9.Manage plant supplies and raw materials inventory.
Role of engineers:
1.Plant engineers oversee the electrical mechanical systems of a manufacturing plant, from installation to troubleshooting.
2. They are called upon to improve the plant's efficiency, upgrade to new technologies, repair equipment, increase production, and reduce manufacturing issues .
3.Try to process on a model of proposed plant before committing large sum of money on a production unit.
4.Examination of the formula to determine its ability to withstand batch scale & process modification.
5.Evaluation & Validation for process and equipment.
6.To identify the critical features of the process.
Guidelines for production & process controls.
7.To provide master manufacturing formula with instructions for manufacturing procedure.
8.To avoid the scale up problems.
Process of solid ,liquid dosage forms and their guidelines followed along with proper equipment study is provided and the major controls to maintain scale up consideration were mentioned.
Technology Transfer in Pharma Industry, Technology Transfer in Pharmaceutical Industry, Pharmaceutical Technology Transfer, Pharma Tech Transfer, Naseeb basha, Pharmaceutical Tech Transfer, Naseeb basha Technology Transfer in Pharma Industry, Naseeb basha Pharmaceutical Technology Transfer
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
Video Lecture is available at https://www.youtube.com/watch?v=DXu_CLgB4q0
Introduction, terminology/definitions and rationale, advantages, disadvantages, selection of drug candidates. Approaches to design-controlled release formulations based on diffusion, dissolution and ion exchange principles. Physicochemical and
biological properties of drugs relevant to controlled release formulations.
It is the topic of Industrial pharmacy 2 from semester 7 of Bachelor of pharmacy.
It involved all information regarding Pharmaceuticals production scale up technique .role of managers, Engineer and scientists are explained properly .
ROLE OF MANAGER
1. Ensure a safe work environment for all pilot plant operations and compliance with all health and safety policies and procedures.
2.Provide technical leadership and operational oversight of Pilot Plant facility.
3.Partner with Process Development to optimize and implement new processes and technology at the pilot scale.
4.Train engineers and associates in the functional tasks necessary to successfully perform their duties.
5.Schedule activities of pilot plant personnel and ensure the tasks are completed in a timely manner.
6.Provide personnel career development, coaching, and feedback including performance management discussions with each direct report.
7.Train and oversee compliance with Quality Assurance policies and procedures that relate to the Pilot Plant.
8.Write and review standard operating procedures, batch records, process deviations reports, CAPAs, and change control requests.
Manage raw material receipt and release system.
9.Manage plant supplies and raw materials inventory.
Role of engineers:
1.Plant engineers oversee the electrical mechanical systems of a manufacturing plant, from installation to troubleshooting.
2. They are called upon to improve the plant's efficiency, upgrade to new technologies, repair equipment, increase production, and reduce manufacturing issues .
3.Try to process on a model of proposed plant before committing large sum of money on a production unit.
4.Examination of the formula to determine its ability to withstand batch scale & process modification.
5.Evaluation & Validation for process and equipment.
6.To identify the critical features of the process.
Guidelines for production & process controls.
7.To provide master manufacturing formula with instructions for manufacturing procedure.
8.To avoid the scale up problems.
Process of solid ,liquid dosage forms and their guidelines followed along with proper equipment study is provided and the major controls to maintain scale up consideration were mentioned.
When looking to agglomerate material fines, both pelletizing and compaction granulation are often explored. This presentation looks at the differences between these two processes, as well as the advantages and disadvantages to each.
The Gram stain is a fundamental technique in microbiology used to classify bacteria based on their cell wall structure. It provides a quick and simple method to distinguish between Gram-positive and Gram-negative bacteria, which have different susceptibilities to antibiotics
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
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NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
2. Introduction
Objectives of the Pilot Plant
Significance of pilot plant
Pilot plant design for tablets
◦ Typical unit operations
3. Defined as a part of the pharmaceutical
industry where a lab scale formula is
transformed into a viable product by the
development of liable practical procedure
for manufacture.”
R&D
Pilot
Plant
Produ-
ction
4. Scale
up
Art of designing of prototype using the data
obtained from the pilot plant model.
5. To produce physically and chemically stable
therapeutic dosage forms.
Review of the processing equipment.
Guidelines for productions and process control.
Evaluation and validation.
To identify the critical features of the process.
To provide master manufacturing formula.
6. Examination of formulae.
Review of range of relevant processing equipment.
Production rate adjustment.
Idea about physical space required.
Appropriate records and reports to support GMP.
Identification of critical features to maintain quality.
7. Each stage considered carefully from
experimental lab batch size to intermediate
and large scale production.
Same process, same equipment but
different performance when amount of
material increased significantly.
May involve a major process change that
utilizes techniques and equipment that
were either unavailable or unsuitable on a
lab scale.
8. Material handling
Dry blending
Granulation
Drying
Reduction of particle size
Blending
◦ Dry blending
◦ Direct compression
◦ Slugging (Dry granulation)
9. Granulation handling and feed system
Compression
Tablet coating
10.
11.
12.
13. In lab: materials scooped, dumped or
poured by hand.
May work well for small or intermediate
scale productions.
Large scale productions: mechanical means
necessary.
Simple means: post hoist devices, devices
for lifting, and tilting drums.
Sophisticated: vacuum loading systems,
screw feed systems and meter pumping
systems.
14. Type of system selected depends on the
characteristics of the material, e.g., density.
Material handling system should cause
no/minimum loss of material.
Lengthy transfer more material loss.
If one system being used for more than one
material cross contamination should be
avoided.
Accomplished by using validated cleaning
procedures.
16. Powders granulated prior to tabletting well
blended to ensure proper mixing.
Inadequate blending drug content
uniformity variation (more when drug conc/n
is low) high or low potency.
Large batch blended in batches ensuring no
lump and agglomerate formations.
17. Problems of improper blending:-
◦ Flow problem through the equipment
◦ Non-reproducible compression
◦ No content uniformity.
Screening and/or milling of the ingredients
prior to blending done to make the process
more reliable and reproducible.
18. Equipment used for blending are:
◦ V- blender
◦ Double cone blender
◦ Ribbon blender
◦ Slant cone blender
◦ Bin blender
◦ Orbiting screw blenders vertical and horizontal high
intensity mixers.
Scale up considerations
◦ Time of blending .
◦ Blender loading.
◦ Size of blender.
21. The most common reasons given to justify
granulating are:
a) To impart good flow properties to the material,
b) To increase the apparent density of the powders,
c) To change the particle size distribution,
d) Uniform dispersion of active ingredient.
Traditionally, wet granulation has been
carried out using:
◦ Sigma blade mixer
◦ Heavy-duty planetary mixer (100-200kgs)
24. Wet granulation
can also be
prepared using
tumble blenders
equipped with
high-speed
chopper blades.
25. These greatly affect the granulating time as
well as the granulating fluid relative to that
used in experimental laboratories trials.
High shear mixers often more effective in
densifying light powders, but require large
amount of energy and have limited load size.
Now-a-days equipment involving
continuous process are in use.
26. Advantages:-
◦ Less space and manpower.
◦ Less handling of materials since they are closed
systems.
◦ Reduce danger of personnel exposure to potent
materials.
◦ Prevent from potentially hazardous substances.
27. Binders:
◦ Used in tablet formulations to make powders more
compressible and to produce tablets that are more
resistant to breakage during handling.
◦ In some instances the binding agent imparts
viscosity to the granulating solution (when
dissolved in granulating solution) as a result
transfer of fluid becomes difficult.
◦ This problem can be overcome by adding some or
all binding agents in the dry powder prior to
granulation.
29. Some granulation, when prepared in production sized
equipment, take on a dough-like consistency and may
have to be subdivided to a more granular and porous
mass to facilitate drying.
This can be accomplished by passing the wet mass
through an oscillating type granulator with a suitably
large screen or a hammer mill with either a suitably
large screen or no screen at all.
30. The most common conventional method
circulating hot air oven, which is heated by
either steam or electricity.
Scale-up considerations for an oven drying
operation are:
◦ airflow
◦ air temperature, and
◦ the depth of the granulation on the trays.
31. Too deep or too dense bed makes the drying
process inefficient, and if soluble dyes are
involved, migration of the dye to the surface
of the granules.
Drying times at specified temperatures and
airflow rates must be established for each
product, and for each particular oven load.
32. Fluidized bed dryers are
an attractive alternative
to the circulating hot air
ovens.
The important factor
considered as part of
scale up fluidized bed
dryer are optimum
loads, rate of airflow,
inlet air temperature and
humidity.
33. Uniformity of Content
tablet weight uniformity
Compressibility Tablet hardness
Compression Tablet color
Flowability
factors uniformity
34. Problems due to improper particle size:
◦ Too large particle size- insufficient filling of the die
cavity- weight variation
◦ For colored granulation- coarser the granulation-
mottling
◦ Too many fines- flowability problems- wt variation
◦ Capping (also occurs if speed of the press in
increased).
35. Oscillating granulator
(for not too hard
oversized granulation)
Equipments Hammer mill
Mechanical sieving
device
Screening device
36. Speed of
the mill
Control
factors
Rate of Type of
material feed equipment
38. Use of lubricants & glidants:
◦ In lab: added to the final blend
◦ Scale up: added to the dry granulation during size
reduction
◦ This is done because additives like magnesium
stearate, agglomerate when added in large
quantities to the granulation in a blender.
◦ Over mixing or under mixing should be avoided.
39. Blender Mixing
loads speed
Mixing
Design
Control time
factors
40. Particle size
Mixing
Shape
Hardness
Density
Dynamics of the
mixing action
Segregation
41. Characteristics of the material:
◦ Fragile particles or agglomerates: more readily
abbraided more fines improper mixing flow
problems, fill problems, content uniformity problems.
◦ Particle abbraision is more when high-shear mixing with
spiral screws or blades are used.
◦ Tumble blenders: for prolonged mixing
◦ Bulk density of raw materials considered in selection of
the blender and determining optimum blender load.
◦ Excessive granulation: poor content uniformity, poor
lubrication & improper color dispersion.
42. “Direct Compression” is defined as the process by which
tablets are compressed directly from powder mixture of
API and suitable excipients.
No pretreatment of the powder blend by wet or dry
granulation procedure is required.
Direct compression is one of the most advanced
technologies to prepare tablets.
Requires only blending and compression of excipients.
Economical process.
Suitable for heat and moisture sensitive API.
Not suitable for very low and very high dose drugs.
43.
44.
45. Particle characteristics (mixing & segregation): size,
size distribution, shape, static charge
Blender load
Optimum mixing speed
Blending time
Optimizing the process and validation of its
performance
46. Order of addition of components to the
blender
Mixing speed: can be varied with the original
direction as necessary.
Mixing time: excessive mixing may fracture
the fragile excipients and ruin their
compressibility.
Use of auxiliary dispersion material within the
mixer (chopper blade in a twin shell mixer):
◦ Increase efficiency
◦ Reduce agglomerates
47. Mixing action:
◦ Determined by the mechanics of the mixer.
◦ Changed by converting from one blender to the
other or by modifying the blender through addition
of baffles or plates, which would alter the mixing
characteristics.
Blender load: affects efficiency
◦ Overload: reduced free flow of granules and
reduced efficiency
◦ Localized concentration: content uniformity
◦ Small load: sliding and rolling of powders in the
blender, no proper mixing & increased time for
mixing.
48. 1. Simple
2. Requires least complicated equipment
3. Requires minimum amount of handling and
operator time
4. Modification in the process is easy
5. Free flowing granules can be obtained without the
granulating solution.
6. Saves time and energy necessary to volatilize the
solvent used in conventional granulation powders
49. 7. Suitable for thermolabile and moisture sensitive
API’s
8. Chances of batch-to-batch variation are negligible,
because the unit operations required for
manufacturing processes is fewer.
9. Particle size uniformity
50. Excipient Related
1. Problems in the uniform distribution of low dose
drugs.
2. High dose drugs having high bulk volume, poor
compressibility and poor flowability are not suitable
for direct compression. For example, Aluminium
Hydroxide, Magnesium Hydroxide
3. Direct compression diluents and binders must possess
both good compressibility and good flowability.
4. Many active ingredients are not compressible either in
crystalline or amorphous forms.
5. May lead to unblending because of difference in
particle size or density of drug and excipients.
Similarly the lack of moisture may give rise to static
charges, which may lead to unblending.
6. Non-uniform distribution of colour, especially in
tablets of deep colours.
51. Process Related
i) Capping, lamination, splitting, or layering of tablets
related to air entrapment during direct
compression. When air is trapped, the resulting
tablets expand when the pressure of tablet is
released, resulting in splits or layers in the tablet.
ii) In some cases require greater sophistication in
blending and compression equipment.
iii) Expensive equipment
52. For dry powder blend that cannot be directly
compressed because of poor flow or compression
properties.
Done on a tablet press designed for slugging.
Pressure of 15 tons; normal: 4 tons or less
Speed is slow since poorly flowable powders require
more time to be compressed.
Diameter of slugs:
◦ 1 inch for more easily slugged material
◦ ¾ inch for materials difficult to compress
54. Materials of very low density require roller
compaction to achieve a bulk density sufficient to
allow encapsulation or compression. E.g.-
densification of aluminium hydroxide
55. Additional handling can affect content uniformity of
the drug and the particle size distribution.
Segregation due to static charges may lead to flow
problems through tablet press hoppers and feed
frames.
This affects tablet weight, thickness and hardness.
Finally poor content uniformity.
More sophisticated equipment cleaning problem.
Equipment to be engineered for efficient and total
cleaning.
Well written, documented and validated cleaning
procedures are essential for such systems.
56. Functions of a tablet press:
1. Filling of empty die cavity with granulation.
2. Precompression of granulation (optional).
3. Compression of granules.
4. Ejection of the tablet from the die cavity and take-
off of compressed tablet.
Potential problems such as sticking to the punch
surface, tablet hardness, capping, and weight
variation detected.
57. Control factors while selecting the speed of the press:
1. Granulation feed rate.
2. Delivery system should not change the particle size
distribution.
3. System should not cause segregation of coarse and
fine particles, nor it should induce static charges.
The die feed system must be able to fill the die
cavities adequately in the short period of time that
the die is passing under the feed frame.
The smaller the tablet , the more difficult it is to get a
uniform fill at high press speeds.
58. Slowing down the press speed or using larger
compression rollers can often reduce capping in a
formulation.
High level of lubricant or over blending can result in a
soft tablet, decrease in wettability of the powder and
an extension of the dissolution time.
Binding to die walls can also be overcome by
designing the die to be 0.001 to 0.005 inch wider at
the upper portion than at the center in order to
relieve pressure during ejection.
64. The tablets must be sufficiently hard to withstand the
tumbling to which they are subjected in either the
coating pan or the coating column.
Some tablet core materials are naturally hydrophobic,
and in these cases, film coating with an aqueous
system may require special formulation of the tablet
core and/or the coating solution.
A film coating solution found to work well with a
particular tablet in small lab coating pan may be
totally unacceptable on a production scale.
65. This is because of increased pressure & abrasion to
which tablets are subjected when batch size is large &
different in temperature and humidity to which tablets
are exposed while coating and drying process.