Quality control tests are important to ensure tablets meet standards for safety, efficacy and patient acceptability. Key tests include weight variation, hardness, friability, disintegration and dissolution. Weight variation tests if individual tablet weights match the average weight. Hardness ensures tablets can withstand manufacturing and handling stresses. Friability tests surface strength and disintegration confirms how quickly tablets break down in fluid. Dissolution determines the rate of drug release.
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.
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 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.
QUALITY CONTROL OF TABLETS IPQC stands for in process quality control. These are checks that are carried out before the manufacturing process is completed.
Everyone requires a product of the best quality, be it in case of medicines or any other edibles or services. Hence, the presentation deals with the quality control of tablets
In Process Quality Control System (IPQC) for Solid Dosages Form (Tablets)Gaurav kumar
This presentation pertains to the in-process tests performed during the manufacturing process of the solid dosages form (tablets).
The presentation covers the methods and the permissible limits for the tests performed.
These tests are of great importance as these not only ensure quality product but also upholds the cGMP.
Multi-source connectivity as the driver of solar wind variability in the heli...Sérgio Sacani
The ambient solar wind that flls the heliosphere originates from multiple
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holes and slow-speed, highly variable, streams whose source regions are
under debate. A key goal of ESA/NASA’s Solar Orbiter mission is to identify
solar wind sources and understand what drives the complexity seen in the
heliosphere. By combining magnetic feld modelling and spectroscopic
techniques with high-resolution observations and measurements, we show
that the solar wind variability detected in situ by Solar Orbiter in March
2022 is driven by spatio-temporal changes in the magnetic connectivity to
multiple sources in the solar atmosphere. The magnetic feld footpoints
connected to the spacecraft moved from the boundaries of a coronal hole
to one active region (12961) and then across to another region (12957). This
is refected in the in situ measurements, which show the transition from fast
to highly Alfvénic then to slow solar wind that is disrupted by the arrival of
a coronal mass ejection. Our results describe solar wind variability at 0.5 au
but are applicable to near-Earth observatories.
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Since volcanic activity was first discovered on Io from Voyager images in 1979, changes
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Binocular Telescope, show evidence of a major resurfacing event on Io’s trailing hemisphere. When compared to the most recent spacecraft images, the SHARK-VIS images
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optics at visible wavelengths.
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
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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,
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Richard's aventures in two entangled wonderlandsRichard Gill
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(May 29th, 2024) Advancements in Intravital Microscopy- Insights for Preclini...Scintica Instrumentation
Intravital microscopy (IVM) is a powerful tool utilized to study cellular behavior over time and space in vivo. Much of our understanding of cell biology has been accomplished using various in vitro and ex vivo methods; however, these studies do not necessarily reflect the natural dynamics of biological processes. Unlike traditional cell culture or fixed tissue imaging, IVM allows for the ultra-fast high-resolution imaging of cellular processes over time and space and were studied in its natural environment. Real-time visualization of biological processes in the context of an intact organism helps maintain physiological relevance and provide insights into the progression of disease, response to treatments or developmental processes.
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Slides from:
11th International Conference on Electrical, Electronics and Computer Engineering (IcETRAN), Niš, 3-6 June 2024
Track: Artificial Intelligence
https://www.etran.rs/2024/en/home-english/
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.
3. Introduction:
• Tablets are a solid dosage form of medicaments with or
without excipients which are prepared by compression or
moulding method and intended for oral administration for
local and systemic effect.
• They may vary in its size shape and weight depending on the
medicament and its mode of administration.
Why there is a need to perform Quality control tests
for tablets?
• To ensure safety,potency,efficacy,stability,patient acceptability
and patient compliance of tablet.
• To check wheather a pharmaceutical tablet satisfy certain
standards to claim it to be a quality drug or not.
• To check that the quality parameters are within the acceptance
limits or not.
4. What is Quality control?
• Quality control is a small part of QA and it is concerned with
sampling,testing and documentation during manufacturing and
also after completion of manufacturing.
• It is the monitoring process through which manufacturer
measures actual quality performance,compares it with
standards and find out the causes of deviation from standard to
ensure quality product not once but every time.
• In general terms,Quality control refers to a procedure or a set
of steps taken during the manufacturing of a product to ensure
that it meets requirements and that the product is reproducible.
5. Types of Quality control tests
1.Official tests
• Weight variation test
• Drug content
• Disintegration time test
• Dissolution test
2.Unofficial tests
• Thickness
• Hardness
• Friability
• Organoleptic characters
6. 1.ORGANOLEPTIC CHARACTERS:
Colour:
• Many pharmaceutical tablets use color as a vital means of rapid
identification and consumer acceptance.
• The colour of a product must be uniform within a single tablet.Non-
uniformity is referred to as ‘mottling’ and hence it leads to poor
quality of product.
Odour:
• The presence of odor in a batch of tablets could indicate stability
problems, such as the odor of acetic acid in degrading aspirin
tablets.
• However, the presence of an odor could be characteristic for the
drug (vitamins), added ingredients (flavoring agents) or the dosage
form (film-coated tablets).
Taste:
• Taste is important in consumer acceptance of, especially,
chewable tablets.
7. 2.WEIGHT VARIATION TEST:
• According to the USP, weight variation test is run by weighing 20
tablets individually calculating the average weights and comparing
the individual tablet weights to the average. The value of weight
variation test is expressed in percentage. The following formula is
used:
Weight Variation = (IW - AW)/AW X 100%
Where,
IW: Individual weight
AW: Average weight
Factors responsible for weight variation:
Flow properties
Degree of segregation
8. Official standards:
As per U.S.P.
As per I.P.
Sr.No
.
Average weight of tablet % weight variation
acceptable(+ or -)
1. 130 or less mg (+ or -) 10%
2. 130-324 mg (+ or -) 7.5%
3. >324 mg (+ or -) 5%
Sr.No. Average weight of tablet % weight variation
acceptable(+ or -)
1. 84 or less mg (+ or -) 10%
2. 84-250 mg (+ or -) 7.5%
3. >250 mg (+ or -) 5%
9. Note:
• If we are using 20 tablets,then according to U.S.P.,not more
than 2 tablets show % weight variation.
• If we are taking 10 tablets,then according to U.S.P.,not more
than 1 tablet show % weight variation.
3. THICKNESS TEST:
• Tablet thickness is determine by the diameter of the tablet.
Micrometer and vernier caliper are used for checking tablet
thickness.
• Thickness should be controlled within ± 5% variation of a
standard value.
• Thickness must be controlled for consumer acceptance of the
product, and to facilitate packaging.
Factors affecting thickness:
Size and size distribution
Compression force
10. Equipments used in this test:
A. Micrometer: Here,put the
tablet between two anvils and
read it’s thickness by scale.
It is measured in micrometer(mm).
B. Vernier caliper: Here,
tablet is put between two
jaws of vernier caliper and
measure thickness of tablet
by reading scale.It is
measured in centimeter(cm).
11. Note:
• As per official standard,tablet thickness variation alloted upto
(+ or -) 5% of standard value.
4.HARDNESS TEST:
• This test is also known as “Crushing Strength Test”.
• Tablets require a certain amount of strength, or hardness to
withstand mechanical shocks of handling in manufacture,
packaging and shipping
• Tablet hardness has been defined as the force required to break
a tablet in a diametric compression test.
Factors affecting hardness:
Concentration of binder
Moisture content
Compression force
12. Equipments used in this test:
(a)Monsanto hardness tester
(b)Pfizer hardness tester
(c)Strong cobb hardness tester
(d)Erweka hardness tester
• Out of the above equipments,Monsanto hardness tester and
Pfizer are commonly used to determine hardness of tablet.
(a)Monsanto hardness tester:
Here,tablet is put between
moving jaw and fixed jaw.
Moving jaw is moved and
pressure is applied on
tablet by means of screw
knob.The point where
tablet get break down,it is
recorded by means of
scale.The hardness is measured in Kg/cm2.
13. (b) Pfizer hardness tester:
The Pfizer tester compresses
tablet between a holding anvil
and a piston connected to a
force-reading gauge when its
plier-like handles are gripped.
The point where tablet gets
break down,it is noted by reading gauze.
Official standards for Hardness:
• 5-8 kg/cm2 for standard compressed tablet except
Effervescent tablet,Dispersible tablet,Orodispersible
tablet,Chewable tablet,etc.
• More than 8-12 kg/cm2 for Sustain released tablet and
controlled release tablet.
14. 5.FRIABILITY TEST:
• “FRIABILITY is the phenomenon where the surface of the
tablet is damage or shown a site of damage due to mechanical
shock.”
• PURPOSE: To evaluate the ability of the tablets to withstand
the breakage during the transportation and handling.
• Friability testing is a method, which is employed to determine
physical strength of uncoated tablets upon exposure to
mechanical shock and attrition. In simple words, friability test
tells how much mechanical stress tablets are able to withstand
during their manufacturing, distribution and handling by the
customer.
• It means Surface Erosion by certain mechanical shock and
lost of material from intact tablet.
15. Equipment used in this test:
Roche friabilator tester is most commonly used for determining %
friability of tablet.
Procedure:
1.Take 20 tablets and take initial
weight of it and put it into friabilator.
2.Now rotate the drum at 25 rpm per
min or 100 rpm for 4 mins.
3.During this,tablet gets dropped on
plastic from 6 inches, it will pass
through mechanical shocks.
4.After 4 minutes,calculate final weight
of tablets and that of % friability.
% Friability can be calculated by following formula-
% Friability = W1 – W2/W1 × 100
Where,
W1 = weight of tablets before testing
W2 = weight of tablets after testing.
16. Standards for friability:
• % Friability should be upto 0.5 to 1% for all standard
compressed tablets.
• For effervescent,chewable,WHISKERING,orodispersible
tablets % friability should be greater than 1.
6. DISINTEGRATION TEST:
• Disintegration is a process in which tablets are break up into
granules or smaller particles.
• The time it takes a tablet to disintegrate is measured in a
device described in the USP/NF.So, disintegration test is a
measure of the time required for a group of tablets to break up
into particles under a given set of conditions.
• This test is essential for tablets intended for administration by
mouth, except those intended to be chewed before being
swallowed or those that should dissolve slowly in the mouth,
e.g., lozenges, glyceryl trinitrate, or effervescent tablets. Also,
disintegration does not apply to some types of sustained-
release tablets.
17. Disintegration time: Time required for breaking of tablet into small
particles under influence of disintegrating fluid.
• Disintegrating fluid may be either simulated gastric fluid or
simulated intestinal fluid.
Equipment used in this test:
Disintegration test apparatus is commonly used.
18. Apparatus construction:
• Two batches of six tablets can be simultaneously tested with this
instrument.
• The USP device to test disintegration uses 6 glass tubes that are 3
inches long,open at the top,and held against a 10-mesh screen at the
bottom end of basket rack assembly.Each glass tube has percolated
sieve (no.10) at the bottom.
Procedure:
• To test for disintegration time,one tablet is placed in each tube,and
the basket rack is positioned in a 1-L beaker of water,simulated
gastric fluid or simulated intestinal fluid,at 37◦C±2◦C ,such that
tablets remain 2.5 cm below the surface of liquid on their upward
movement and descend not closer than 2.5 cm from the bottom of
beaker.
• A standard motor-driven is used to move the basket assembly
containing the tablets up and down through a distance of 5-6 cm at
frequency of 28-32 cycles per minute.Thus, in this way,note the time
required to complete disappearance of tablet from glass tube.
19. Official standards:
Sr.No
.
Types I.P. B.P. U.S.P.
1. Standard compressed
tablet(Uncoated)
15 mins 15 mins 5 mins
2. Sugar coated tablet 60 mins 30 mins ---
3. Film coated tablet 30 mins 30 mins ---
4. Enteric coated tablet 1 hr. 1-2 hrs 2 hrs
5. Effervescent tablet or
dispersible tablet
<3 mins <3 mins <3 mins
6. Orodispersible tablet <1 min <1 min <1 min
Note:
•The disintegration time is not for buccal,sublingual and chewable
tablets.Beacuse they are directly absorbed.
•No disintegration time for sustained release and controlled release
tablets.
20. 7.DISSOLUTION TEST:
• The administration of drugs via oral dosage forms is one of the most
common and effective means of delivering treatments to patients.
When a dosage form is swallowed, the rate at which it releases the
active ingredient is critical to ensure that the drug is delivered
properly. The rate at which the drug is released is called the
dissolution rate.
• Several dissolution apparatuses exist. In (USP) ,there are four
dissolution apparatuses standardized and specified. They are:
(A)USP Dissolution Apparatus 1 – Basket (37 °C)
(B)USP Dissolution Apparatus 2 – Paddle (37°C)
(C)USP Dissolution Apparatus 3 – Reciprocating Cylinder(37 °C)
(D)USP Dissolution Apparatus 4 – Flow-Through Cell (37 °C)
• According to I.P.,
Type I : Paddle type apparatus
Type II : Basket type apparatus
21. Equipments used in this test:
[1] Rotating basket apparatus:
Assembly consists of:
• A covered vessel
• Metallic drive shaft
• Cylindrical basket
• Motor
• Sample port
• Water bath holding temperature
37◦C ± 0.5◦C
• Acidic media or alkaline media
22. [2]Rotating paddle apparatus:
Assembly consists of:
• A covered vessel
• Metallic drive shaft
• Stainless steel paddle
• Motor
• Sinker to prevent floating of
tablet
• Water bath holding tempe
-rature at 37◦C ± 0.5◦C
• Acidic media or alkaline
media
23. Standards:
Sr.No
.
Stages No. of units Acceptance criteria
1. S1 6 tablets All units ‘6’ not less than Q +
5%
2. S2 6 tablets Average of 12 tablets equal to
or not > Q and Q-15%
3. S3 12 tablets Average of 24 tablets is equal to
or not >Q and Q-25%
Where,
Q=% drug dissolved
Note: 75% of drug should be dissolved within 45 mins as per
U.S.P.
24. 8.CONTENT UNIFORMITY TEST:
• Content uniformity test was developed to ensure content
consistency of active drug substances .
Factors affecting drug content:
Tablet weight variation.
Uneven distribution of the drug in the powder or granules
Segregation of the powder mixture or granulation during
formulation processes
• By the USP method, 30 tablets are randomly selected, 10 of
these tablets are assayed individually according to the method
described in the individual monograph.
• Unless otherwise stated in the monograph, the requirements
for content uniformity are met if the amount of active
ingredient in nine (9) of the ten (10) tablets lies within the
range of 85% to 115% of the label claim.
25. • The tenth tablet may not contain less than
75% or more than 125% of the labelled drug
content. If one or more dosage units do not
meet these criteria, the remaining 20 tablets
are assayed individually and none may fall
outside of the 85% to 115% range for the
batch to be accepted.
26. Conclusion:
• Quality control of tablets involves various tests which
require keen attention.
• To ensure that established product quality standards
are met, these tests must be performed during
production (in process control)and verified after the
production of each batch.