The document summarizes the key steps in the tablet manufacturing process, including weighing, milling, mixing, granulation, drying, compression, coating, and packaging. It describes the main methods of tablet production as wet granulation, dry granulation, and direct compression. Quality control tests mentioned are content uniformity, disintegration testing, and dissolution testing. Personnel required are production pharmacists, manufacturing chemists, analytical chemists, and machine operators. Common equipment used includes mills, mixers, granulators, dryers, tablet presses, and coating pans.
Granulation process may be defined as a process wherein small particles adhere together by forming bonds between them , resulting in the formation of large aggregates called granules.
Granulation process may be defined as a process wherein small particles adhere together by forming bonds between them , resulting in the formation of large aggregates called granules.
Glass as a packaging material in pharmaceutical packagingShweta Shelke
This presentation gives a brief idea about the types of glasses used in pharmaceutical industry and its intended use. Different tests used for assuring its quality for intended use.
The chapter deals with the preformulation studies that have to be considered while designing a dosage form and developing a formulation that is suitable for a patient. Here, physical and chemical properties of a drug substance are studied along with biopharmaceutical classification of drugs. Also a detailed study on the application of preformulation studies in different dosage forms are also studied.
Glass as a packaging material in pharmaceutical packagingShweta Shelke
This presentation gives a brief idea about the types of glasses used in pharmaceutical industry and its intended use. Different tests used for assuring its quality for intended use.
The chapter deals with the preformulation studies that have to be considered while designing a dosage form and developing a formulation that is suitable for a patient. Here, physical and chemical properties of a drug substance are studied along with biopharmaceutical classification of drugs. Also a detailed study on the application of preformulation studies in different dosage forms are also studied.
The most common tablet manufacturing process techniques are wet granulation, dry granulation, and direct compression.
Your active pharmaceutical ingredients’ (APIs) physical and chemical stability influences manufacturing.
For successful tablet manufacturing, you need granulators, mixing equipment, drying machinery, and coating systems.
Even if you’re using the right equipment to manufacture your product, there is a wide range of common tablet defects that can occur that affect quality.
There are several goals to aim for during the tablet manufacturing process:
Develop tablets that are strong and hard enough to hold up against mechanical shock during manufacturing, packaging, shipping, and dispensing
Formulate tablets that are uniform in weight and drug content
Manufacture bioavailable products according to indication requirements
Create chemically and physically stable tablets that last over long periods
Formulate products that are free of defects and have an elegant finish
pellets can be defined as multi particulate system or multiunit system
They are spherical particulates manufactured by agglomeration of the powder granules containing drug substance and excipients.
Pellets can be prepared by a special technique called Pelletization.
This technique is referred to an agglomeration process that convert fine powder or granules of bulk drug or excipient in to small , free flowing , spherical or semi spherical pellets .
Multi particular drug delivery system especially suitable for achieving controlled delay released oral formulation with low risk of dose dumping, flexibility of blending to attain different release patterns as well as reproducible and short gastric residence time.
Multi particulate drug delivery system are mainly oral dosage form consisting of a multiplicity of small discrete units each exhibiting some desire characteristics.
Slide 1: Title Slide
Extrachromosomal Inheritance
Slide 2: Introduction to Extrachromosomal Inheritance
Definition: Extrachromosomal inheritance refers to the transmission of genetic material that is not found within the nucleus.
Key Components: Involves genes located in mitochondria, chloroplasts, and plasmids.
Slide 3: Mitochondrial Inheritance
Mitochondria: Organelles responsible for energy production.
Mitochondrial DNA (mtDNA): Circular DNA molecule found in mitochondria.
Inheritance Pattern: Maternally inherited, meaning it is passed from mothers to all their offspring.
Diseases: Examples include Leber’s hereditary optic neuropathy (LHON) and mitochondrial myopathy.
Slide 4: Chloroplast Inheritance
Chloroplasts: Organelles responsible for photosynthesis in plants.
Chloroplast DNA (cpDNA): Circular DNA molecule found in chloroplasts.
Inheritance Pattern: Often maternally inherited in most plants, but can vary in some species.
Examples: Variegation in plants, where leaf color patterns are determined by chloroplast DNA.
Slide 5: Plasmid Inheritance
Plasmids: Small, circular DNA molecules found in bacteria and some eukaryotes.
Features: Can carry antibiotic resistance genes and can be transferred between cells through processes like conjugation.
Significance: Important in biotechnology for gene cloning and genetic engineering.
Slide 6: Mechanisms of Extrachromosomal Inheritance
Non-Mendelian Patterns: Do not follow Mendel’s laws of inheritance.
Cytoplasmic Segregation: During cell division, organelles like mitochondria and chloroplasts are randomly distributed to daughter cells.
Heteroplasmy: Presence of more than one type of organellar genome within a cell, leading to variation in expression.
Slide 7: Examples of Extrachromosomal Inheritance
Four O’clock Plant (Mirabilis jalapa): Shows variegated leaves due to different cpDNA in leaf cells.
Petite Mutants in Yeast: Result from mutations in mitochondrial DNA affecting respiration.
Slide 8: Importance of Extrachromosomal Inheritance
Evolution: Provides insight into the evolution of eukaryotic cells.
Medicine: Understanding mitochondrial inheritance helps in diagnosing and treating mitochondrial diseases.
Agriculture: Chloroplast inheritance can be used in plant breeding and genetic modification.
Slide 9: Recent Research and Advances
Gene Editing: Techniques like CRISPR-Cas9 are being used to edit mitochondrial and chloroplast DNA.
Therapies: Development of mitochondrial replacement therapy (MRT) for preventing mitochondrial diseases.
Slide 10: Conclusion
Summary: Extrachromosomal inheritance involves the transmission of genetic material outside the nucleus and plays a crucial role in genetics, medicine, and biotechnology.
Future Directions: Continued research and technological advancements hold promise for new treatments and applications.
Slide 11: Questions and Discussion
Invite Audience: Open the floor for any questions or further discussion on the topic.
Seminar of U.V. Spectroscopy by SAMIR PANDASAMIR PANDA
Spectroscopy is a branch of science dealing the study of interaction of electromagnetic radiation with matter.
Ultraviolet-visible spectroscopy refers to absorption spectroscopy or reflect spectroscopy in the UV-VIS spectral region.
Ultraviolet-visible spectroscopy is an analytical method that can measure the amount of light received by the analyte.
The increased availability of biomedical data, particularly in the public domain, offers the opportunity to better understand human health and to develop effective therapeutics for a wide range of unmet medical needs. However, data scientists remain stymied by the fact that data remain hard to find and to productively reuse because data and their metadata i) are wholly inaccessible, ii) are in non-standard or incompatible representations, iii) do not conform to community standards, and iv) have unclear or highly restricted terms and conditions that preclude legitimate reuse. These limitations require a rethink on data can be made machine and AI-ready - the key motivation behind the FAIR Guiding Principles. Concurrently, while recent efforts have explored the use of deep learning to fuse disparate data into predictive models for a wide range of biomedical applications, these models often fail even when the correct answer is already known, and fail to explain individual predictions in terms that data scientists can appreciate. These limitations suggest that new methods to produce practical artificial intelligence are still needed.
In this talk, I will discuss our work in (1) building an integrative knowledge infrastructure to prepare FAIR and "AI-ready" data and services along with (2) neurosymbolic AI methods to improve the quality of predictions and to generate plausible explanations. Attention is given to standards, platforms, and methods to wrangle knowledge into simple, but effective semantic and latent representations, and to make these available into standards-compliant and discoverable interfaces that can be used in model building, validation, and explanation. Our work, and those of others in the field, creates a baseline for building trustworthy and easy to deploy AI models in biomedicine.
Bio
Dr. Michel Dumontier is the Distinguished Professor of Data Science at Maastricht University, founder and executive director of the Institute of Data Science, and co-founder of the FAIR (Findable, Accessible, Interoperable and Reusable) data principles. His research explores socio-technological approaches for responsible discovery science, which includes collaborative multi-modal knowledge graphs, privacy-preserving distributed data mining, and AI methods for drug discovery and personalized medicine. His work is supported through the Dutch National Research Agenda, the Netherlands Organisation for Scientific Research, Horizon Europe, the European Open Science Cloud, the US National Institutes of Health, and a Marie-Curie Innovative Training Network. He is the editor-in-chief for the journal Data Science and is internationally recognized for his contributions in bioinformatics, biomedical informatics, and semantic technologies including ontologies and linked data.
This pdf is about the Schizophrenia.
For more details visit on YouTube; @SELF-EXPLANATORY;
https://www.youtube.com/channel/UCAiarMZDNhe1A3Rnpr_WkzA/videos
Thanks...!
THE IMPORTANCE OF MARTIAN ATMOSPHERE SAMPLE RETURN.Sérgio Sacani
The return of a sample of near-surface atmosphere from Mars would facilitate answers to several first-order science questions surrounding the formation and evolution of the planet. One of the important aspects of terrestrial planet formation in general is the role that primary atmospheres played in influencing the chemistry and structure of the planets and their antecedents. Studies of the martian atmosphere can be used to investigate the role of a primary atmosphere in its history. Atmosphere samples would also inform our understanding of the near-surface chemistry of the planet, and ultimately the prospects for life. High-precision isotopic analyses of constituent gases are needed to address these questions, requiring that the analyses are made on returned samples rather than in situ.
Earliest Galaxies in the JADES Origins Field: Luminosity Function and Cosmic ...Sérgio Sacani
We characterize the earliest galaxy population in the JADES Origins Field (JOF), the deepest
imaging field observed with JWST. We make use of the ancillary Hubble optical images (5 filters
spanning 0.4−0.9µm) and novel JWST images with 14 filters spanning 0.8−5µm, including 7 mediumband filters, and reaching total exposure times of up to 46 hours per filter. We combine all our data
at > 2.3µm to construct an ultradeep image, reaching as deep as ≈ 31.4 AB mag in the stack and
30.3-31.0 AB mag (5σ, r = 0.1” circular aperture) in individual filters. We measure photometric
redshifts and use robust selection criteria to identify a sample of eight galaxy candidates at redshifts
z = 11.5 − 15. These objects show compact half-light radii of R1/2 ∼ 50 − 200pc, stellar masses of
M⋆ ∼ 107−108M⊙, and star-formation rates of SFR ∼ 0.1−1 M⊙ yr−1
. Our search finds no candidates
at 15 < z < 20, placing upper limits at these redshifts. We develop a forward modeling approach to
infer the properties of the evolving luminosity function without binning in redshift or luminosity that
marginalizes over the photometric redshift uncertainty of our candidate galaxies and incorporates the
impact of non-detections. We find a z = 12 luminosity function in good agreement with prior results,
and that the luminosity function normalization and UV luminosity density decline by a factor of ∼ 2.5
from z = 12 to z = 14. We discuss the possible implications of our results in the context of theoretical
models for evolution of the dark matter halo mass function.
1. JSS College of Pharmacy, Mysuru
Tablet manufacturing process
Prepared by :
Avinasha S
1st M Pharm (QA)
JSSCP
Submitted to:
Mr Hemanth Kumar S
Dept of Pharmaceutics
JSSSCP
2. JSS College of Pharmacy, Mysuru
INTRODUCTION
• Tablets are commonly manufactured by wet granulation, dry
granulation or direct compression. These methods may be
considered to consist of a series of steps (unit processes) –
weighing, milling, mixing, granulation, drying, compaction,
(frequently) coating and packaging. Regardless of the method
used the unit processes – weighing, milling and mixing, are
the same; subsequent steps differ.
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3. JSS College of Pharmacy, Mysuru
Primary goals of tablet manufacturing process
• To formulate tablets that are strong and hard to withstand
mechanical shock encountered during manufacturing, packing,
shipping, dispensing and use.
• To formulate tablets that are uniform in weight and in drug content.
• To formulate tablets that are bioavailable according to indication
requirements.
• To formulate tablets that are chemically and physically stable over a
long period of time.
• To formulate tablets that have elegant product identity which is free
from any tablet defects.
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Personnel requirements during manufacture of
pharmaceutical tablets
• Production pharmacists/ supervisors
• Manufacturing chemist
• Analytical chemist
• Quality assurance manager
• Machine operators
• Mechanics
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5. JSS College of Pharmacy, Mysuru
Tablet Manufacturing Equipment/ Machines
Common equipment used in pharmaceutical
tablet manufacturing include:
1. Size reduction equipment
e.g., Hammer mill , roller mill , fluidized
energy mill , cutter mill and ball mill
2. Weighing balance/ balances e.g., bulk
weighing balance (weighs in kilogram),
electronic weighing balance (weighs in
grams and milligrams).
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7. JSS College of Pharmacy, Mysuru
4. Granulators e.g. , Rotating
shape granulators , dry granulator ,
high shear granulator etc
5. Drying equipment e.g. spray
dryer , rotary dryer , fluidized bed
dryer etc
6. Tableting machine e.g. single
punch tablet press and multi station
/rotary tablet press
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8. JSS College of Pharmacy, Mysuru
7. Quality control equipment
e.g., disintegration equipment , USP
Dissolution Tester, Tablet Hardness Tester,
Tablet Thickness Tester, Tablet Friability
Testers etc.
8. Coating and polishing machines for
coated tablets e.g., standard coating pan,
perforated pan, fluidized bed/ Air
suspension coating system etc.
9. Packaging machines e.g., blister
packaging machines, strip packing
machine, aluminium foil packaging
machine, etc.
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Layout of Tablets manufacturing
section
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Procedure for Manufacturing Tablets
• Dispensing: Each ingredient in the tablet formula is
weighed and accurately dispensed as per dose. This is
one of the critical steps in any type of formulation
process and should be done under technical
supervision.
• Sizing: Formulation ingredients must be in finely
divided form, otherwise, size reduction should be
carried out for better flow property and easy mixing.
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11. JSS College of Pharmacy, Mysuru
• Powder blending: Powders are mixed using a
suitable blender to obtain a uniform and
homogeneous powder mix. The drug substance and
excipients are mixed in geometric dilution.
• Granulation: Here small powder particles are
gathered together into layers, and permanent
aggregates to render them into free-flowing states.
• Drying and dry screening: Screened wet granules
need to be dried for a particular time period in tray
dryer or fluid bed dryer at controlled temperature not
exceeding 550 degree C . Dried granules are screened
through the appropriate mesh screen
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12. JSS College of Pharmacy, Mysuru
• Tablet compression: This step involves the
compression of granules into a flat or convex, round,
oblong, or unique shaped, scored or unscored tablets;
engraved with an identifying symbol and/ or code
number using tablet press.
• Coating: Tablets and granules are coated if there is
need to mask the unpleasant taste/odour of some drug
substance or to increase the aesthetic appeal of
uncoated tablets as well as to modify the release or
control the release of drug substance from tablets.
This is achieved by enclosing or covering the core
tablet or granules with coating solutions.
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Methods used in tablet Formulation
Tablets are commonly manufactured by
• Wet granulation
• Dry granulation or
• Direct compression
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14. JSS College of Pharmacy, Mysuru
WET GRANULATION
• Wet granulation is a widely used method for
the production of compressed tablet. It is
essentially a process of size enlargement
involving several steps and the use of an
adhesive substance known as binder.
• The granules produced using this method of
granulation has a greater probability of
meeting all the physical requirements for
tablet formation.
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FLOW CHAT OF WET GRANULATION
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Methods:
1. Weighing, milling and mixing of the APIs with
powdered excipients (excluding the lubricant)
2. Preparation of binder solution
3. Mixing of binder solution with powders to
form a damp mass
4. Screening the dampened powder into pellets
or granules (wet screening) using 6- to 12-mesh
screen
5. Drying of moist granules
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6. Sizing the granulation by dry screening using
14- to 20-mesh screen
7. Mixing of the dried granules with lubricant
and disintegrates
8. Compression of granules into tablets
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DRY GRANULATION
• The formation of granules by compacting
powder mixtures into large pieces or compacts
which are subsequently broken down or sized
into granules (often referred to as dry
granulation, double compression or pre-
compression) is a possible granulation method
which, however, is not widely used in the
manufacture of tablets.
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Flow chat of dry granulation
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Dry granulation method
• Weighing and Milling of formulation
ingredients (drug substance and excipients)
• Mixing of milled powders.
• Compression of mixed powders into slugs.
• Milling and sieving of slugs.
• Mixing with disintegrate and lubricant.
• Compression into tablet.
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DIRECT COMPRESSION
• direct compression involves direct
compression of powdered materials into tablets
without modifying the physical nature of the
materials itself.
• Direct compression avoids many of the
problems associated with wet and dry
granulations.
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Its successful application in tablet formulation
rests on two fundamental issues:
• The availability of suitable excipients
• The availability of suitable machinery.
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Flow chat of direct compression
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Dry granulation method .
• Milling of therapeutic agent and excipients
• Mixing of milled powders, disintegrates and
lubricants
• Compression into tablet
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Quality control of tablets
Official tests
• Content of active ingredient/ absolute drug
content test/ assay of active ingredient.
• Weight uniformity test/ weight variation test
• Content uniformity test
• Disintegration time test
• Dissolution test
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• UNIFORMITY OF CONTENT
As per IP : 10mg / less than 10% w/w of active
ingredient
As per BP/USP : 25mg /less than 25%w/w
• DISINTEGRATION TEST
As per IP : 28-32 cycle per min
As per BP/USP : 29-32 cycle per min
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Disintegration testing condition and interpretation (IP)
Sr.
No
Type of tablets Medium Temperatu
re
Limit
1 Uncoated Water/buffer 37 °± 2 °C 15 min or as per individual
monograph
2 Film coated Water 37 °±2 °C 30 min or as per individual
monograph
3 Sugar coated Water/0.1 N
HCl
37 °±2 °C 60 min or as per individual
monograph
4 Dispersible
Tablets
Water 25 °±1 °C 03 min or as per individual
monograph
5 Effervescent
Tablets
Water 25 °±5 °C 05 min or as per individual
monograph
6 Enteric-coated
Tablets
0.1 M HCl
mixed
phosphate
buffer pH 6.8
37 °±2 °C 02 hour in HCl: no disintegration
60 min in buffer : disintegrate
7 Soluble Tablets Water 20 °±5 °C 03 minutes
29. JSS College of Pharmacy, Mysuru
Disintegration testing condition (USP)
Sr.
No
Type of tablets Medium Temperatu
re
Limit
1 Uncoated Water/as specified
in monograph
37 °± 2 °C As per individual monograph
2 Coated Water/as specified
in monograph
37 °±2 °C As per individual monograph
4 Enteric-coated
Tablets
Simulated gastric
fluid TS
Simulated
intestinal fluid TS
37 °±2 °C 01 hour in Simulated gastric fluid
As per individual monograph:
Simulated intestinal fluid TS
5 Buccal Tablets Water/as specified
in monograph
37 °± 2 °C 4 hour
6 Sublingual
tablets
Water/as specified
in monograph
37 °± 2 °C As per individual monograph
30. JSS College of Pharmacy, Mysuru
non-official tests
• hardness test
• Friability test
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Packaging and storing of tablets
Before tablets are sent out for distribution, they
are usually packaged using appropriate
packaging materials. The type of packaging
material used is a matter of choice and is
dependent on several factors including:
• The degree of protection required
• Compatibility of the packaging material
with the formulation.
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32. JSS College of Pharmacy, Mysuru
• Presentation, particularly for those products
which may be the subject of impulse buying
• Customer convenience in terms of size,
weight, method of opening or reclosing
legibility of printing, etc.
• Filling method and Cost
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