Hard and soft gelatin capsules are solid dosage forms that contain medications enclosed in gelatin shells. Hard capsules have two-piece shells while soft capsules have one-piece shells. Capsules are manufactured through dip coating or rotary die processes then inspected, counted, packaged, and stored under controlled temperature and humidity conditions to maximize shelf life.
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.
Alternative to gelatin capsule,mainly focused on non animal origin,explained and market product included in this,most of vegetarian people wont eat animal so we come to new non animal origin region like plants those are HPMC capsule,Pullulan capsule,PVA capsule,Alginatecapsule...
It is a new topic which is recently developed in pharmacy field. Here i have mentioned the drugs suitable, compatibility studies,methods of preparation and also their applications
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.
Alternative to gelatin capsule,mainly focused on non animal origin,explained and market product included in this,most of vegetarian people wont eat animal so we come to new non animal origin region like plants those are HPMC capsule,Pullulan capsule,PVA capsule,Alginatecapsule...
It is a new topic which is recently developed in pharmacy field. Here i have mentioned the drugs suitable, compatibility studies,methods of preparation and also their applications
The presentation deals with a detailed study of soft gelatin capsules. this involves the production of soft gelatin capsule based on the importance of base adsorption factor and minim/gram factor. also quality control studies was also elaborated.
The presentation deals with a detailed study of soft gelatin capsules. this involves the production of soft gelatin capsule based on the importance of base adsorption factor and minim/gram factor. also quality control studies was also elaborated.
I Omkar B. Tipugade , M-Pharm, Sem 4th , Department of Pharmaceutics , Shree Santkrupa College Of Pharmacy, Ghogaon. Today I published the hard gelatin & Soft Gelatin Capsule in brief .
Its All About Capsule...
i tried to explain in short...
hope you liked it..
please like and share to all students,
which are want to more study in minimum time..
Thank You..
also join on whatsapp to bring newthings
contact no. 9765763626
Solid unit dosage forms the drug is enclosed within the water-soluble shell or an envelope either a hard or soft shell. Shell is typically made of gelatin primarily intended for oral delivery and provides a rapid release of contents.
Generally, the shells are formed from gelatin.
Scope of Pharmacy 1 Prof morning Batch 2021Tehmina Adnan
Introduction and orientation to the Profession of Pharmacy concerning Hospital Pharmacy, Retail Pharmacy, Industrial Pharmacy, Forensic Pharmacy, Pharmaceutical education and research etc
Pharmacy Orientation Gp B Evening Batch 2021Tehmina Adnan
a. Introduction and orientation to the Profession of Pharmacy in relation to Hospital Pharmacy, Retail Pharmacy, Industrial Pharmacy, Forensic Pharmacy, Pharmaceutical education and research etc
Pharmacy orientation Gp A Evening Batch 2021Tehmina Adnan
a. Introduction and orientation to the Profession of Pharmacy in relation to Hospital Pharmacy, Retail Pharmacy, Industrial Pharmacy, Forensic Pharmacy, Pharmaceutical education and research etc
Title: Sense of Smell
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 primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
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
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
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.
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
- 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
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
CDSCO and Phamacovigilance {Regulatory body in India}NEHA GUPTA
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. Operating under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, the CDSCO is responsible for approving new drugs, conducting clinical trials, setting standards for drugs, controlling the quality of imported drugs, and coordinating the activities of State Drug Control Organizations by providing expert advice.
Pharmacovigilance, on the other hand, is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The primary aim of pharmacovigilance is to ensure the safety and efficacy of medicines, thereby protecting public health.
In India, pharmacovigilance activities are monitored by the Pharmacovigilance Programme of India (PvPI), which works closely with CDSCO to collect, analyze, and act upon data regarding adverse drug reactions (ADRs). Together, they play a critical role in ensuring that the benefits of drugs outweigh their risks, maintaining high standards of patient safety, and promoting the rational use of medicines.
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
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 lecture slides, by Dr Sidra Arshad, offer a quick overview of the 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 lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
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. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
1. PRESENTED BY;
Umer tanveer. Roll No R-47 CMS 11-2019
Izhan Siddiqui. Roll No R-56 CMS 119-2019
Syed Bilal Hussain. Roll No R-89 CMS 38-2019
Zumair Ali. Roll No R-91 CMS 115-2019
Abdul hannan. Roll No. R-01 CMS 102-2019
TOPIC : PHARMACEUTICAL CAPSULES DOSAGE FORM
2. Introduction
• What is capsule?
Capsules are solid dosage forms in which drug and/or inert substances are enclosed in a
gelatin shell. The gelatin shell may be hard or soft depending on their composition. The
word capsule is derived from the Latin word capsula, meaning a small box. The shells may
be composed of two pieces, a body and a cap, or they may be composed of a single piece.
Two piece capsules are commonly referred to as hard-shell capsules, and one-piece
capsules are often referred to as soft-shell capsules.
advantages of capsules:
• They are slippery when moist and hence, easy to swallow with a draught of water.
• The shells are physiologically inert and easily and quickly digested in the GIT.
• The shells can be opacified with Tio2(titanium dioxide) or coloured to give protection
from light.
Disadvantages of capsules:
• Efflorescent cause capsules to soften & deliquescent may dry the capsule shell to
brittleness.
• Capsule are not suitable for liquids that dissolve gelatin. Such as aqueous or
hydroalcoholic solution.
3. Hard gelatin capsules
• Hard gelatin capsules also known as hard-shell gelatin capsules or two-piece capsules are solid dosage
forms in which one or more medicinal agents or inert materials are enclosed within a small shell.
• A hard gelatin capsule shell consists of two prefabricated, cylindrical sections a cap and a body each of
which has one rounded, closed-end and one open end. The body has a slightly lower diameter than the
cap and fits inside the cap.
Components:
Hard gelatin capsule shell is composed largely of gelatin. Other than gelatin, it may contain materials such as
plasticizer, colourants, opacifying agents, and preservatives which either enable capsule formation or
improve their performance. Hard gelatin capsules also contain 12–16% water, but the water content can vary,
depending on the storage conditions.
4. size and shape:
Empty hard gelatin capsule shells come in a variety of sizes
ranging from an arbitrary numbering of 000 to 5 with 000 being
the largest size and 5 being the smallest.
5. Manufacturing of hard shell capsules:
Hard gelatin capsules are manufactured using a dip-coating method and the various
stages involved are as follows:
• Step 1: Preparation of the gelatin solution (dipping solution)
• Step 2: Dip-coating the gelatin solution on to metal pins (moulds)
• Step 3: Rotation of the Dip-coated pins
• Step 4: Drying of the gelatin-coated pins
• Step 5: Stripping and trimming
• Step 6: Joining of the trimmed capsule shell
• Step 7: Printing
6. Filling of capsules
The basic steps in filling hard gelatin capsules include:
1. Rectification of capsules (placing empty gelatin capsules on the removable plate
with bodies facing downward).
2. Separation of caps from bodies.
3. Dosing of fill material (The body is filled with the formulation manually using a
plastic spatula, and the excess powder is removed).
4. Replacement of caps/ closing capsule shells and
5. Ejection of filled capsules
7.
8. SOFT GELATIN CAPSULES
1. Soft gelatin capsules are made of gelatin to which glycerin or a
polyhydric alcohol such as sorbitol has been added.
2. Soft gelatin capsules, which contain more moisture than hard
capsules, may have a preservative, such as methylparaben and/or
propylparaben, to retard microbial growth.
3. Soft gelatin capsules may be oblong, oval, or round. They may be
single colored or two-toned and may be imprinted with identifying markings.
4. As with hard gelatin capsules, they may be prepared with opaquants
to reduce transparency and render characteristic features to the capsule shell.
9. MANUFACTURING OF SOFT GELATIN CAPSULES :
PLATE PROCESS
1. Place the gelatin sheet over a die plate containing numerous die
pockets.
2. Application of vacuum to draw the sheet in to the die pockets
3. Fill the pockets with liquid or paste.
4. Place another gelatin sheet over the filled pockets
5. Sandwich under a die press where the capsules are formed and
cut out.
10. ROTARY DIE PROCESS:
1. this machine the soft gelatin capsules are prepared & then filled
immediately with liquid medicaments it is having two hoppers & two
rotating dies
2. Liquid mixture is placed in one hopper & the liquid medicament in
other Hooper.
3. The two rotating dies rotate in opposite directions when the fluid
gelatin mixture enters the machine from the hopper it produces two
continuous ribbons .
4. These half shell of the capsule is formed.
11. 5. At this stage the measured quantity of the medicament is filled in
to it with the stroke of a pump with the subsequent movement of the
dies the other half capsule is formed.
6. The two halves' of the capsules are sealed together by the heat &
pressure of the rotating dies.
7. As the die rolls rotate, the convergence of the matching die pockets
seals and cuts out
the filled capsules.
12. USE OF SOFT GELATIN CAPSULES
Soft gelatin capsules are prepared to contain a variety of liquid, paste, and
dry fi lls. Liquids that may be encapsulated into soft gelatin capsules include the
following.
1. Water-immiscible volatile and nonvolatile liquids such as vegetable and
aromatic oils, aromatic and aliphatic hydrocarbons, chlorinated hydrocarbons,
ethers, esters, alcohols, and organic acids.
2. Water-miscible nonvolatile liquids, such as polyethylene glycols, and
nonionic surface active agents, such as polysorbate 80.
3. Water-miscible and relatively nonvolatile compounds such as propylene
glycol and isopropyl alcohol, depending on factors such as concentration used and
packaging conditions.
13.
14.
15.
16.
17.
18. INSPECTION OF CAPSULES:
In order to ensure optimal appearance quality, capsules are inspected for a broad
spectrum of defects, including deformation, cracks, burrs, presence of foreign particl
and discoloration. One of the method for inspection is The Seidenader ATI which is
automatic machine. It inspects the surface of plain or coated tablets, the ACI to inspe
hard gelatin capsules, throughout the rate up to 3000 units/min depending on the
product.
During the inspection process, the
good capsule is compared with others
and termed rejected if they are;
. Undersize, oversize, de shaped
capsules, opaque, leaked, joint, air
bubble in gelatin shell, different color
shades.
19. COUNTING OF CAPSULES:
The method for counting and dispensing the capsules or tablets depends on simple
vibrating, sloped and concave shaped (V-shaped) trough, having a number of
descending steps. The vibration of trough is adjusted and controlled by a
microprocessor. The vibration in the trough, is patterned to provide a great vibratory
amplitude. The microprocessor electronically adjust the input vibration to the
trough, such that the flow of materials is adjusted for different type of materials.
This causes the capsules to align in accurately within the trough.
20. PACKAGING OF CAPSULES:
Drug packaging can be broadly classified into four categories – primary,
secondary, tertiary and quaternary packaging. Primary packaging is a
material that envelops the product, impart barrier from immediate
environment to protect its activity and holds it. Secondary packaging is
outside the primary packaging that group primary packs together.
Tertiary packaging is used for bulk storage and transportation, whereas
quaternary packaging utilizes huge containers for shipment to another
territory or port. Polyvinyl chloride is the most common used
packaging material due to its low cost, flexibility and ease of
thermoforming. Other than this, aluminum, cyclic olefin copolymers,
cellulose polymers are also used.
21. Blister packaging is most common and widely accepted world-
over as primary pack of tablets or capsules due to its efficacy
and safety considerations. Alternative to blister packs is strip
packaging or glass vial with a sealed cap. Blister packs are
convenient and cost effective as they offer optimization of dose
and manufacturing process thereby utilizing resources
effectively. It is useful for protecting drugs against external
factors, such as humidity and microbial contamination for
extended period of time as well as offers a degree of
mechanical resistance from physical tampering.
22. STORAGE OF CAPSULES:
Correct storage and packaging are important to achieve maximum product
shelf life and achieve target quality levels. A capsule is a very sensitive
product and it must be protected against excessive heat and humidity. For
storage a temperature between 15 to 25C and a relative humidity between
35 to 65% is to be maintained. At a very low humidity, capsule loses
moisture and becomes brittle. At a very high humidity, it becomes flaccid
and loses shape. For hard gelatin capsule a relative humidity of 45-55%
should be maintained to maintain the 12-16% of the moisture content of
capsule.