Capsules are solid dosage forms that contain a drug or mixture of drugs enclosed within a shell. The shell is typically made of gelatin but can also be other materials. Capsules are intended for oral administration and provide rapid release of contents unless they are modified or enteric release capsules. Capsules can be filled using various methods like auger, dosator, or dosing disc systems. Tests are conducted to ensure uniformity of contents, weight, and dissolution based on pharmacopeial standards.
IPQC Tests for capsules As per IP, BP & USPPramod Ramane
IPQC- In Process Quality Control Tests for Capsules are
1. Uniformity Of Content
2. Disintigration Test
3. Weight Variation Test
4. Dissolution Test
The tests are with Acceptance limits/Criteria as per Indian Pharmacopoeia (IP), British Pharmacopoeia (BP) & United States Pharmacopoeia (USP)
IPQC?
Its Need
In-Process Quality Control tests for Tablets
Hardness
Friability
Thickness
Disintegration Time
Weight variation
Content uniformity
Dissolution test
Leakage testing for strip and blister packaging
In Process Quality Control Tests (IPQC) for Solid Dosage FromSagar Savale
IPQC is concerned with providing accurate, specific, & definite descriptions of the procedures to be employed, from, the receipt of raw materials to the release of the finished dosage forms.
IPQC Tests for capsules As per IP, BP & USPPramod Ramane
IPQC- In Process Quality Control Tests for Capsules are
1. Uniformity Of Content
2. Disintigration Test
3. Weight Variation Test
4. Dissolution Test
The tests are with Acceptance limits/Criteria as per Indian Pharmacopoeia (IP), British Pharmacopoeia (BP) & United States Pharmacopoeia (USP)
IPQC?
Its Need
In-Process Quality Control tests for Tablets
Hardness
Friability
Thickness
Disintegration Time
Weight variation
Content uniformity
Dissolution test
Leakage testing for strip and blister packaging
In Process Quality Control Tests (IPQC) for Solid Dosage FromSagar Savale
IPQC is concerned with providing accurate, specific, & definite descriptions of the procedures to be employed, from, the receipt of raw materials to the release of the finished dosage forms.
Introduction to Dissolution equipment's, Calibration of dissolution apparatus, Dissolution procedure development and validation, Dissolution method development for generic drug products.
Quality Control Tests Of Capsules dosage form.
1. Weight Variation Test
2. Content Uniformity Test
3. Dissolution Test
4. Disintegration Test
5. Leak Test
A Primer on Hard Gelatin Capsule ManufacturingVivek Sinha
31/03/2015
Hard gelatin capsule shells are used as soluble containers for incorporation of drugs or nutritional
supplements, usually in the form of powders, pellets or granules in the healthcare industry. They are
commonly intended for oral administration having its advantages over other dosage forms that are
used widely by pharmaceutical companies to develop different medicaments and ensure stability of
the product throughout the shelf life. Since it serves as a major excipient for the manufacture of
pharmaceutical products, the quality attributes of hard capsule shells is very vital for performance
and stability of the final product.
Pharmaceutical products are categorized as high quality and high risk product administered to fight
various types of acute and chronic illnesses where the performance of the product should be
reproducible every time it is administered. The capsule shell consists of two cylindrical parts i.e. the
cap and body; both are open at one extreme. Other extreme of both is hemispherical; the open end
of cap overlaps the open end of body and maintains a closure with a typical lock system. Hence, it is
very important that the product achieves the label claim as set forth and is not contaminated and
readily available to the patients. Benchmarking of developments and manufacturing processes in the
pharmaceutical industry as against other industries led to the concept of Quality by Design or QbD.
Over the past few years, QbD has gained considerable acceptance throughout pharmaceutical
industry and has been successfully applied. The key quality attributes of capsules that determine the
process ability on the high speed filling machine are the dimensional characteristics and weight
variability.
The potential variations of empty hard capsules as an input material and its potential impact on
finished product quality has been studied and high consistency within the specification of the critical
quality parameters is confirmed. Annual product quality review needs to be performed using defined
sampling size against set of verification criteria. The built-in quality approach begins at the
development stage of new product where even factors impacting the performance of hard capsules
i.e. formulation, filling machine type, etc., is given due consideration. The selection of proper raw
material, the process validations and stability studies are to be conducted for suitability. The process
conditions should be maintained along with appropriate in-process quality checks. Final release of
product can be done by QA after product and document review. The data on process capability,
trends of quality parameters, technical specification and the evaluation procedure should be
maintained and submitted based on the current level of quality standards.
Introduction to Dissolution equipment's, Calibration of dissolution apparatus, Dissolution procedure development and validation, Dissolution method development for generic drug products.
Quality Control Tests Of Capsules dosage form.
1. Weight Variation Test
2. Content Uniformity Test
3. Dissolution Test
4. Disintegration Test
5. Leak Test
A Primer on Hard Gelatin Capsule ManufacturingVivek Sinha
31/03/2015
Hard gelatin capsule shells are used as soluble containers for incorporation of drugs or nutritional
supplements, usually in the form of powders, pellets or granules in the healthcare industry. They are
commonly intended for oral administration having its advantages over other dosage forms that are
used widely by pharmaceutical companies to develop different medicaments and ensure stability of
the product throughout the shelf life. Since it serves as a major excipient for the manufacture of
pharmaceutical products, the quality attributes of hard capsule shells is very vital for performance
and stability of the final product.
Pharmaceutical products are categorized as high quality and high risk product administered to fight
various types of acute and chronic illnesses where the performance of the product should be
reproducible every time it is administered. The capsule shell consists of two cylindrical parts i.e. the
cap and body; both are open at one extreme. Other extreme of both is hemispherical; the open end
of cap overlaps the open end of body and maintains a closure with a typical lock system. Hence, it is
very important that the product achieves the label claim as set forth and is not contaminated and
readily available to the patients. Benchmarking of developments and manufacturing processes in the
pharmaceutical industry as against other industries led to the concept of Quality by Design or QbD.
Over the past few years, QbD has gained considerable acceptance throughout pharmaceutical
industry and has been successfully applied. The key quality attributes of capsules that determine the
process ability on the high speed filling machine are the dimensional characteristics and weight
variability.
The potential variations of empty hard capsules as an input material and its potential impact on
finished product quality has been studied and high consistency within the specification of the critical
quality parameters is confirmed. Annual product quality review needs to be performed using defined
sampling size against set of verification criteria. The built-in quality approach begins at the
development stage of new product where even factors impacting the performance of hard capsules
i.e. formulation, filling machine type, etc., is given due consideration. The selection of proper raw
material, the process validations and stability studies are to be conducted for suitability. The process
conditions should be maintained along with appropriate in-process quality checks. Final release of
product can be done by QA after product and document review. The data on process capability,
trends of quality parameters, technical specification and the evaluation procedure should be
maintained and submitted based on the current level of quality standards.
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.
hard and soft gelatin capsule shell manufacturing. preparation of shell fluid, preparation of fill material and manufacturing process. machineries and equipment for capsule manufacturing. stability and quality control
Presentation complied by Drug Regulations – a not for profit organization from publicly available material form FDA , EMA, EDQM . WHO and similar organizations.
Visit www.drugregulations.org for the latest in Pharmaceutic
"Capsula" is derived from the Latin word & Is defined as a solid dosage form in which the medicament contained is enclosed within small shell or container.
How to Make Awesome SlideShares: Tips & TricksSlideShare
Turbocharge your online presence with SlideShare. We provide the best tips and tricks for succeeding on SlideShare. Get ideas for what to upload, tips for designing your deck and more.
Hard gelatin capsules: Introduction, Extraction of gelatin and production of hardgelatin capsule shells. size of capsules, Filling, finishing and special techniques of formulation of hard gelatin capsules. In process and final product quality control tests for capsules.
Soft gelatin capsules
Quality control test for capsule and finish product of capsule are
■ weight variation test
■ Dissolution test
■ Disintegration test
■ moisture permeation test
■ contents uniformity test
■ blooms gelatin strength .
DEFINITION
Capsules are solid preparations with hard and soft shells of various shapes and capacities, usually containing a single dose of active ingredients.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
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
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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
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Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
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. General introduction
• Capsules are solid dosage forms in which the drug or a mixture of drugs is
enclosed in Hard Gelatin Capsule Shells, in soft, soluble shells of gelatin, or in hard
or soft shells of any other suitable material, of various shapes and capacities.
• They usually contain a single dose of active ingredient(s) and are intended for oral
administration.
• Excipients such as opaque fillers, antimicrobial preservatives, sweetening agents,
flavoring agents and one or more coloring agents permitted under the Drugs and
Cosmetic Rules, 1945 may be added.
• Capsules may bear surface markings.
• The contents of capsules may be of solid, liquid or paste-like consistency. They
consist of the medicament(s) with or without excipients such as vehicles, solvents,
diluents, lubricants, fillers, wetting agents and disintegrating agents.
• The contents do not cause deterioration of the shell, but the capsules are attacked
by the digestive fluids thereby releasing the contents. The contents of capsules
other than Modified-release (Sustained-release) Capsules do not contain any
added coloring agent.
3. CAPSULES• solid dosage form
• the drug is enclosed within either a hard or
soft shell
– shell is typically made of gelatin
• primarily intended for oral delivery
• provide a rapid release of contents
B. Amsden 3CHEE 440
4. Filling
• operations involved
– rectification of empty capsules
– separation of caps from bodies
– filling capsule bodies
– replacing caps and ejecting filled capsules
• 3 basic methods for powder filling
– auger or screw
– dosator
– dosing disc
B. Amsden 4CHEE 440
5. Capsule Filling
– auger
• semi-automatic operation
• filling based on volume
• need good powder flow properties
– dosator
• fill based on weight
• continuous operation
B. Amsden 5CHEE 440
6. Capsule Filling– dosing disc
• filled based on weight
• continuous operation
B. Amsden 6CHEE 440
7. Hard Gelatin Capsules
• Advantages
– tasteless and odourless
– swallowing is easy
– flexibility in formulating
– uniquely suitable for blinded clinical trials
– useful for extemporaneous compounding by
pharmacist
• Disadvantages
– tend to be more expensive to produce than tablets
– not suitable for highly soluble salts
B. Amsden 7CHEE 440
9. Soft Gelatin Capsules (Softgels)
• consist of a continuous gelatin shell surrounding a liquid core
• formed, filled, and sealed in one operation
• shells are softened by addition of glycerin or polyhydric
alcohol (ex. sorbitol)
• oblong, spherical, elliptical in shape
B. Amsden 9CHEE 440
11. Soft Capsules
• ADVANTAGES
– may contain liquids, suspensions, pastes
– rapid release of contents
– useful for drugs prone to oxidation
• DISADVANTAGES
– have a greater tendency to adhere to each other
– more expensive
– increased possibility of interactions between drug
and shell
B. Amsden 11CHEE 440
12. Types of capsule
• Hard Gelatin Capsules
• Soft Gelatin Capsules
• Modified-release Capsules
• Enteric Capsules
13. Tests
• Uniformity of container contents
• Content of active ingredients
• Uniformity of content
• Uniformity of weight
• Dissolution
• Disintegration (not applied for
• modified release capsule)
• Leak test
• Locking length
Pharmacopoial
Non- Pharmacopoial
14. Uniformity of container contents /
Contents of Packaged Dosage Forms (IP)
• The following tests and specifications apply to oral dosage forms and
preparations intended for topical use that are packaged in containers in
which the labeled net quantity is not more than 100 g or 300 ml or 1000
units, as the case may be
• For higher labeled quantities the test and limits given in the standards of
Weights and Measures (Packaged commodities) Rules, 1977 may be
followed.
15. Contents of Packaged Dosage Forms
• Test Method
• Select a sample of 10 containers and count the number of capsules in each
container.
• The average number of the contents in the 10 containers is not less than the
labeled amount and the number in any single container is not less than 98 per
cent and not more than 102 per cent of the labeled amount
• If this requirements is not met, count the number of the contents in 10
additional containers. The average number in the 20 containers is not less
than the labeled amount, and the number in not more than 1 of the 20
containers is less than 98 per cent or more than102 per cent of the labeled
amount.
16. • This test is applicable to capsule that contain less than 10 mg or less than 10
per cent w/w of active ingredient (As per IP).
• This test is applicable to capsule that contain less than 25 mg or less than 25
per cent w/w of active ingredient (As per BP/USP ).
• For capsule containing more than one active ingredient carry out the test for
each active ingredient that corresponds to the aforementioned conditions.
• The test for Uniformity of content should be carried out only after the content
of active ingredient(s) in a pooled sample of the capsule has been shown to be
within accepted limits of the stated content.
• The test for Uniformity of content is not applicable to capsule containing
multivitamins and trace elements.
Uniformity of contant (IP)
17. • The test for uniformity of content of single-dose preparations is based on the assay
of the individual contents of active substance(s) of a number of single-dose units
to determine whether the individual contents are within limits set with reference to
the average content of the sample.
• Method.
• Determine the content of active ingredient(s) in each of 10 dosage units taken at
random using the method given in the monograph or by any other suitable
analytical method.
• Acceptance limits
• The preparation complies with the test if not more than one individual content is
outside the limits of 85 to 115 per cent of the average content and none is
outside the limits of 75 to 125 per cent of the average content.
• The preparation fails to comply with the test if more than three individual
contents are outside the limits of 85 to 115 per cent of the average content or if
one or more individual contents are outside the limits of 75 to 125 per cent of the
average content.
Uniformity of content (IP)
18. • If two or three individual contents are outside the limits of 85 to 115 per cent
of the average content but within the limits of 75 to 125 per cent, repeat the
determination using another 20 dosage units.
• The preparation complies with the test if not more than three individual
contents of the total sample of 30 dosage units are outside the limits of 85 to
115 per cent of the average content and none is outside the limits of 75 to 125
per cent of the average content.
Uniformity of contents
19. Uniformity of Weight of Single-Dose
Preparations (IP/BP)
• This test is not applicable to capsules that are required to
comply with the test for Uniformity of content for all active
ingredients.
• Weigh an intact capsule. Open the capsule without losing any
part of the shell and remove the contents as completely as
possible. To remove the contents of a soft capsule the shell
may be washed with ether or other suitable solvent and the
shell allowed to stand until the odour of the solvent is no
longer detectable. Weigh the shell. The weight of the contents
is the difference between the weighing. Repeat the procedure
with a further 19 capsules.
• Determine the average weight.
• Not more than two of the individual weights deviate from the
average weight by more than the percentage shown in the table
and none deviates by more than twice that percentage.
20.
21. Disintegration Test
• For the purpose of this test, disintegration does not imply complete
solution of the dosage unit or even of its active constituent.
• Disintegration is defined as that state in which no residue of the unit
under test remains on the screen of the apparatus or, if a residue
remains, it consists of fragments of disintegrated parts of capsule
component parts such as insoluble coating of the of capsule shells, or
of any melted fatty substance from the pessaries or suppository or is a
soft mass with no palpable core.
• If discs have been used with capsules, any residue remaining on the
lower surfaces of the discs consists only of fragments of shells.
• 28-32 cycle (strokes) per minute IP
• 29-32 cycle (strokes) per minute BP/USP
22. Method
• Unless otherwise stated in the individual monograph, introduce one
capsule into each tube and, if directed in the appropriate general
monograph, add a disc to each tube. Suspend the assembly in the beaker
containing the specified liquid and operate the apparatus for the
specified time.
• Remove the assembly from the liquid. The capsules pass the test if all of
them have disintegrated.
• If 1 or 2 capsules fail to disintegrate, repeat the test on 12 additional
capsules; not less than 16 of the total of 18 capsules tested disintegrate.
• If the capsules adhere to the disc and the preparation under
examination fails to comply, repeat the test omitting the disc. The
preparation complies with the test if all the capsules in the repeat test
disintegrate.
23. For enteric-coated capsule
• Method.
• If capsule having soluble external sugar coating, immerse the basket in
water at room temp for 5 min (USP).
• Put one capsule into each tube, suspend the assembly in the beaker
containing 0.1M hydrochloric acid and operate without the discs for (2
hour as per IP/BP) (1 hour as per USP) , unless otherwise stated in the
individual monograph. Remove the assembly from the liquid.
• No capsule shows signs of cracks that would allow the escape of the
contents or disintegration, apart from fragments of coating.
• Replace the liquid in the beaker with mixed phosphate buffer pH 6.8, add
a disc to each tube and operate the apparatus for a further 60 minutes.
• Remove the assembly from the liquid. If the capsule fails to comply
because of adherence to the disc, repeat the test on a further 6 capsule
without the discs. The capsule pass the test if all six have disintegrated.
24. Disintegration testing condition and interpretation (IP)
Sr.
No
Type of capsule Medium Temperatu
re
Limit
1 Hard gelatin Water/buffer 37 °± 2 °C 30 min or as per individual
monograph
2 Soft gelatin Water 37 °±2 °C 60 min or as per individual
monograph
3 Enteric-coated 0.1 M HCl
mixed
phosphate
buffer pH 6.8
37 °±2 °C 02 hour in HCl: no disintegration
60 min in buffer : disintegrate
25. Disintegration testing condition and interpretation (BP)
Sr.
No
Type of capsule Medium Temperatu
re
Limit
1 Hard gelatin Water/0.1 M
HCl/ Artificial
gastric juice R
37 °± 2 °C 30 min or as per individual
monograph
2 Soft gelatin Water/0.1 M
HCl/ Artificial
gastric juice R
37 °±2 °C 60 min or as per individual
monograph
3 Enteric-coated 0.1 M HCl
mixed
phosphate
buffer pH 6.8
37 °±2 °C 02 hour in HCl: no disintegration
60 min in buffer : disintegrate
26. Disintegration testing condition and interpretation (IP)
Sr.
No
Type of capsule Medium Temperatu
re
Limit
1 Hard gelatin Water/buffer 37 °± 2 °C 30 min or as per individual
monograph
2 Soft gelatin Water 37 °±2 °C 60 min or as per individual
monograph
3 Enteric-coated 0.1 M HCl
mixed
phosphate
buffer pH 6.8
37 °±2 °C 02 hour in HCl: no disintegration
60 min in buffer : disintegrate
27. Dissolution Test
• Use Apparatus 1 unless otherwise directed.
• Use the dissolution medium specified in
• the individual monograph. If the medium is a buffered
solution, adjust the solution so that its pH is within 0.05
units of the pH specified in the monograph.
• Time. Where a single time specification is given in
the monograph, the test may be concluded in a shorter
period if the requirement for the minimum amount
dissolved is met. If two or more times are specified,
specimen are to be withdrawn only at the stated times,
within a tolerance of ± 2 per cent.
28. • Assemble the apparatus and warm the dissolution
medium to 36.5 ° to 37.5 °C unless otherwise stated
• Within the time interval specified, or at each of the
times stated, withdraw a specimen from a zone midway
between the surface of the dissolution medium and the
top of the rotating blade or basket, not less than 10 mm
from the wall of the vessel.
• Except in the case of single sampling, add a volume of
dissolution medium equal to the volume of the samples
withdrawn.
• Perform the analysis as directed in the individual
monograph.
29. Acceptance criteria
Conventional-release dosage forms (IP)
• Unless otherwise specified, the requirements are met if the quantities of
active substance dissolved from the dosage units conform to Table
below . If the results do not conform to the requirements at stage S1
given in the table, continue testing with additional dosage units through
stages S2 and S3 unless the results conform at stage S2.
• Where capsule shells interfere with the analysis, remove the contents
of not less than 6 capsules as completely as possible, and dissolve the
empty capsule shells in the specified volume of the dissolution
medium.
• Perform the analysis as directed in the individual monograph. Make
any necessary correction.
• Correction factors should not be greater than 25 per cent of the stated
amount.
31. Acceptance criteria
• Conventional-release solid dosage forms (BP/USP)
• Unless otherwise specified, the requirements are met if
the quantities of active substance dissolved from the
dosage units tested conform to Table below. Continue
testing through the 3 levels unless the results conform
at either S1 or S2.
• The quantity Q, is the specified amount of dissolved
active substance, expressed as a percentage of the
labeled content; the 5 per cent, 15 per cent, and 25 per
cent values in the Table are percentages of the labeled
content so that these values and Q are in the same
terms.
33. Prolonged-release dosage forms (IP)
• Unless otherwise specified, the requirements are met if
the quantities of active substance dissolved from the
dosage units conform to Table below.
• If the results do not conform to the requirements at stage
L1 given in the table, continue testing with additional
dosage units through stages L2 and L3 unless the results
conform at stage L2.
• The limits embrace each value of D, the amount dissolved
at each specified dosing interval.
• Where more than one range is specified, the acceptance
criteria apply to each range.
34.
35. Prolonged-release dosage forms
(BP/USP)
• Unless otherwise specified, the requirements are met if
the quantities of active substance dissolved from the
dosage units tested conform to Table below.
• Continue testing through the 3 levels unless the results
conform at either L1 or L2.
• Limits on the amounts of active substance dissolved are
expressed in terms of the percentage of labeled
content. The limits embrace each value of Qi, the
amount dissolved at each specified fractional dosing
interval. Where more than one range is specified, the
acceptance criteria apply individually to each range.
36.
37. Modified-release dosage forms (IP)
There are 2 method A & B
Method A & B
Acid stage.
• 750 ml/1000 ml of 0.1M hydrochloric acid
• 36.5º to 37.5º.
• 2 hours
• Perform the analysis of the aliquot using a suitable assay method.
Buffer stage.
• Complete the operations of adding the buffer and adjusting the pH within 5
minutes.
• 250 ml of a 0.2 M buffer and solution
• 36.5º to 37.5º.
• 6.8 ± 0.05
• 45 minutes, or for the specified time.
38. Acceptance criteria (IP)
• ACID STAGE
• The requirements of the test are met if conform to Table below.
Continue the testing through the 3 levels unless the results of
both acid and buffer stages conform at an earlier level
39. Acceptance criteria (IP)
• BUFFER STAGE
• The requirements of the test are met if conform to Table below.
Continue the testing through the 3 levels unless the results of both acid
and buffer stages conform at an earlier level
• The value of D in Table is 75 per cent dissolved unless otherwise
specified.
• The quantity, D, is the specified total amount of active substance
dissolved in both the acid and buffer stages, expressed as a percentage
of the labeled content.
40. Prolonged-release solid dosage forms
(BP/USP)
There are 2 method A & B
Method A & B
Acid stage.
• 750 ml/1000 ml of 0.1M hydrochloric acid
• 36.5º to 37.5º.
• 2 hours
• Perform the analysis of the aliquot using a suitable assay method.
Buffer stage.
• Complete the operations of adding the buffer and adjusting the pH within 5
minutes.
• 250 ml of a 0.2 M buffer and solution
• 36.5º to 37.5º.
• 6.8 ± 0.05
• 45 minutes, or for the specified time.
41. Acceptance criteria (BP/USP)
• ACID STAGE
• Unless otherwise specified, the requirements of this portion of the test are
met if the quantities, based on the percentage of the labeled content of
active substance dissolved from the units tested conform to Table 2.9.3.-3.
Continue testing through the 3 levels unless the results of both acid and
buffer stages conform at an earlier level.
42. Acceptance criteria (BP/USP)
• BUFFER STAGE
• The requirements are met if active substance dissolved from the units tested
conform to Table 2.9.3.-4.
• Continue testing through the 3 levels unless the results of both stages conform at
an earlier level.
• The value of Q in Table 2.9.3.-4 is 75 per cent dissolved unless otherwise specified.
• The quantity, Q, is the specified total amount of active substance dissolved in
both the acid and buffer stages, expressed as a percentage of the labeled
content.
• The 5 per cent, 15 per cent and 25 per cent values in the Table are percentages of
the labeled content so that these values and Q are in the same terms.
43. Dissolution testing condition and interpretation (IP)
Sr.
No
Type of capsule Medium Temperature Limit
1 Hard gelatin Water/buffer 37 °± 5 °C As per tables shown before or As
per individual monograph
2 Soft gelatin Water 37 °±5 °C As per tables shown before or As
per individual monograph
4 Enteric-coated
capsule
0.1 M HCl &
Mixed
phosphate
buffer pH 6.8
37 °±2 °C 02 hour in HCl & 60 min in buffer
As per tables shown before or As
per individual monograph