Capsules have several advantages over tablets like masking unpleasant tastes, being easy to swallow, and requiring fewer excipients. They consist of a shell made of gelatin enclosing the drug formulation. Gelatin capsules come in various sizes and are made through a process involving dipping, spinning, drying, stripping, trimming, and polishing. Stability testing ensures the integrity of the capsule shell and determines shelf life, while uniformity testing confirms consistent drug content between capsules. Dissolution and disintegration tests evaluate how quickly the drug is released from the capsule.
Quality Control Tests Of Capsules dosage form.
1. Weight Variation Test
2. Content Uniformity Test
3. Dissolution Test
4. Disintegration Test
5. Leak Test
In the manufacture of pharmaceuticals, encapsulation refers to a range of dosage forms—techniques used to enclose medicines—in a relatively stable shell known as a capsule, allowing them to, for example, be taken orally or be used as suppositories. The two main types of capsules are:
Hard-shelled capsules, which contain dry, powdered ingredients or miniature pellets made by e.g. processes of extrusion or spheronization. These are made in two halves: a smaller-diameter “body” that is filled and then sealed using a larger-diameter “cap”.
Soft-shelled capsules, primarily used for oils and for active ingredients that are dissolved or suspended in oil.
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol systems; formulation and manufacture of aerosols; Evaluation of aerosols; Quality control and stability studies
Quality Control Tests Of Capsules dosage form.
1. Weight Variation Test
2. Content Uniformity Test
3. Dissolution Test
4. Disintegration Test
5. Leak Test
In the manufacture of pharmaceuticals, encapsulation refers to a range of dosage forms—techniques used to enclose medicines—in a relatively stable shell known as a capsule, allowing them to, for example, be taken orally or be used as suppositories. The two main types of capsules are:
Hard-shelled capsules, which contain dry, powdered ingredients or miniature pellets made by e.g. processes of extrusion or spheronization. These are made in two halves: a smaller-diameter “body” that is filled and then sealed using a larger-diameter “cap”.
Soft-shelled capsules, primarily used for oils and for active ingredients that are dissolved or suspended in oil.
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol systems; formulation and manufacture of aerosols; Evaluation of aerosols; Quality control and stability studies
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.
Pharmaceutical aerosols have been playing a crucial role in the health and wellbeing of millions of people throughout the world for many years. These products include pressurized metered dose inhalers (MDIs), dry powder inhalers (DPIs), nebulizers, sublingual’s, skin sprays (coolants, anaesthetics, etc.) and dental sprays. The technology’s continual advancement, the ease of use, and the more desirable pulmonary-rather-than-needle delivery for systemic drugs has increased the attraction for the pharmaceutical aerosol in recent years.
Many of the tests required for the evaluation of MDIs are similar to those used for other dosage forms. These include description, identification, and assay of the active ingredient; microbial limits; moisture content; net weight, degradation products and impurities (if any); extractable; and any other tests deemed appropriate for the active ingredient.
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 .
These defects can cause serious injury and harm. When this occurs, you should speak with our product liability attorneys in Denver. You may have a viable claim to file a product liability lawsuit against the negligent manufacturer.Capsules are solid dosage forms in which the drug substance is enclosed within either a hard or soft soluble shell. Generally the shells are formed from gelatin. The capsule may be regarded as “container” drug delivery system, which provides a tasteless/odorless dosage form without the need of a secondary coating step, as may be required for tablets.Capsules are one of the essential components of the pharmaceutical sector. They are mainly used to hold dry powder or little pellets of medication and are made using specific machinery and techniques. The capsule's production method entails pharmaceutically active ingredients, additives, and a cover. Every pharmaceutical business understands capsule manufacturing takes time, and the reason is the critical measures.
Hard gelatin capsules - a detailed studyTeny Thomas
The presentation involves a descriptive study on hard gelatin capsules which includes the production of the hard gelatin capsule shell, size of the capsules, capsule filling machines and the finishing techniques. The presentation also involves the special techniques of capsule formulation and the quality control tests of hard gelatin capsules
A detailed study on every aspects of parenteral :- introduction, preformulation factors, essential requirements, vehicles and additives, isotonicity, production procedure, facilities, and controls, container and closure selection and finally the quality control evaluation of parenterals.
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.
Pharmaceutical aerosols have been playing a crucial role in the health and wellbeing of millions of people throughout the world for many years. These products include pressurized metered dose inhalers (MDIs), dry powder inhalers (DPIs), nebulizers, sublingual’s, skin sprays (coolants, anaesthetics, etc.) and dental sprays. The technology’s continual advancement, the ease of use, and the more desirable pulmonary-rather-than-needle delivery for systemic drugs has increased the attraction for the pharmaceutical aerosol in recent years.
Many of the tests required for the evaluation of MDIs are similar to those used for other dosage forms. These include description, identification, and assay of the active ingredient; microbial limits; moisture content; net weight, degradation products and impurities (if any); extractable; and any other tests deemed appropriate for the active ingredient.
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 .
These defects can cause serious injury and harm. When this occurs, you should speak with our product liability attorneys in Denver. You may have a viable claim to file a product liability lawsuit against the negligent manufacturer.Capsules are solid dosage forms in which the drug substance is enclosed within either a hard or soft soluble shell. Generally the shells are formed from gelatin. The capsule may be regarded as “container” drug delivery system, which provides a tasteless/odorless dosage form without the need of a secondary coating step, as may be required for tablets.Capsules are one of the essential components of the pharmaceutical sector. They are mainly used to hold dry powder or little pellets of medication and are made using specific machinery and techniques. The capsule's production method entails pharmaceutically active ingredients, additives, and a cover. Every pharmaceutical business understands capsule manufacturing takes time, and the reason is the critical measures.
Hard gelatin capsules - a detailed studyTeny Thomas
The presentation involves a descriptive study on hard gelatin capsules which includes the production of the hard gelatin capsule shell, size of the capsules, capsule filling machines and the finishing techniques. The presentation also involves the special techniques of capsule formulation and the quality control tests of hard gelatin capsules
A detailed study on every aspects of parenteral :- introduction, preformulation factors, essential requirements, vehicles and additives, isotonicity, production procedure, facilities, and controls, container and closure selection and finally the quality control evaluation of parenterals.
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
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.
In the changing scenario of pharmacy practice in India, for successful practice of
Hospital Pharmacy, the students are required to learn various skills like drug distribution,
drug dispensing, manufacturing of parenteral preparations, drug information, patient
counselling, and therapeutic drug monitoring for improved patient care
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3. DEFINITION:-
These are solid dosage form ofmedicaments,
in which drug and some other ingredients is
enclosed within the shells made up of gelatin.
4. ADVANTAGES OF CAPSULES
• Capsules mask the taste and odour of unpleasant drugs
and can be easily administered.
• They are slippery when moist and hence easy to swallow
with a draught of water.
• As compared to tablets less adjuncts are required.
• The shells are physiologically inert and easily and
quickly digested in the gastrointestinal tract.
• They are economical .
• They are easy to handle and carry.
5. DISADVANTAGES OF CAPSULES
The drugs which are hygroscopic absorb water
from the capsule shell making it brittle and hence are
not suitable for filling into capsules.
The concentrated solutions which require previous
dilution are unsuitable for capsules because if
administered as such lead to irritation of stomach.
6. These capsules are made up of gelatin blends,
small amount of certified dyes, opaqueness ,
plasticizers and preservatives.
7. Certified Dyes
Colour approved by D & C act.
Opacifiers
Titanium dioxide.
Plasticizers
Sorbitol, Glycerin.
Preservatives
Propyl and Methyl Parabens.
8. Gelatin is heterogeneous product derived by
hydrolytic extraction of animal's collagen.
The sources of gelatins including animal bones,
hide portions and frozen pork skin.
TYPES OF GELATIN
Type A
Type B
GELATIN
9. TYPE A
Derived from acid treated precursor that
exhibits an iso electric point at pH-9. It is
manufactured mainly from pork skin. Plasticity
and clarity
TYPE B
Derived from alkali treated precursor that
exhibits an iso electric point at pH-4.7. It is
manufactured mainly from animal bones .
tough and brittle
11. Steps involved in making empty gelatin
capsules…
Dipping
Spinning
Drying
Stripping
Trimming and Joining
Polishing.
12.
13. Dipping :
Pairs of the stainless steel pins are dipped into
the dipping solution to simultaneously form the
caps and bodies.
The dipping solution is maintained at a
temperature of about 500C in a heated, jacketed
dipping pan.
Spinning :
The pins are rotated to distribute the gelatin
over the pins uniformly and to avoid the
formation of a bead at the capsule ends.
14. 14
Drying :
The gelatin is dried by a blast of cool air to form
a hard shells.
The pins are moved through a series of air
drying kilns to remove water
Stripping :
A series of bronze jaws strip the cap and body
portions of the capsules from the pins.
15. 15
The stripped cap and body portions are
trimmed to the required length by stationary
knives.
After trimming to the right length, the cap and
body portion are joined and ejected from the
machine.
16. 16
Size Volume in ml Size in mm
000 1.37 26.3
00 0.95 23.7
0 0.68 21.8
1 0.50 19.2
2 0.37 18.3
3 0.30 15.3
4 0.21 14.7
5 0.15 11.9
17. 17
*The largest size of the capsule is No: 000.
*The smallest size is No: 5.
*The standard shape of capsAules is traditional,
symmetrical
bullet shape.
18. Types materials filling into hard
gelatin capsules
Dry solids : powder, pellets, granules
Semisolids : suspensions or pastes
Liquids : non aqueous liquids
Filled by depending up on the capsule
size
19. FILLING OF HARD GELATIN
CAPSULES
• Hand operated hand gelatin capsule
filling method
A hand gelatin capsule filling machine consists of
• A bed with 200 – 300 holes
• A capsule loading tray
• A powder tray
• A pin plate having 200 – 300 pines
number of holes on the bed and capsule loading tray
• A lever
• A handle
• A plate fitted with rubber
20. 20
Various Filling Machine Available…
Eli-lily and Co.
Farmatic.
Hofliger and Karg.
Zanasi.
Parke-Davis.
These machine differ in there design and
output
22. Filling capsule with a
semisolid mass
1. Pipe
materials are sufficiently plastic .it can be rolled in to a
adjustable diameter of pipe with slightly less diameter in to
the capsules .the materials are through in to the capsules
with the help of spatula or knife
2.Semisolid pour
it’s a easy method compared to pipe method because of
in pipe method maintain the satisfactory temp other wise
its make a melting its difficult to pour and seriously
change the cap
24. 24
Pan Polishing : Acela-cota pan is used to dust and
polish.
Cloth Dusting : Capsule are rubbed with cloth.
Brushing : Capsule are feed under soft rotating
brush.
Storage
Finished capsules normally contain an equilibrium
moisture content of 13-16%.
To maintain a relative humidity of 40-60% when
handling and storing capsules
26. 26
1. STABILITY TESTS.
a) Shell integrity test
b) Determination of shelf life
2.INVARIABILITY TESTS.
a ) Weight variation
b) Content uniformity
3. DISINTEGRATION TEST.
4. DISSOLUTION TEST.
5. MOISTURE PERMEATION TEST.
27. Stability tests for capsules are performed to know
the integrity of gelatin capsule shell ( but not to
know the stability of therapeuticallay active agent )
and for determining the shelf life of capsules.
The tests helps in improving the quality of contents
of capsule shell and for choosing the appropriate
retail package.
BEFORE ACTUALLY PERFORMING THE TESTS
FOLLOWING FACT:
(i).the capsule shell are to be stabilized to know
atmospheric condition with relative humidity
about 20-30 % and temperature about 21-24⁰c .
27
28. A ) SHELL INTEGRITY TEST :
▪ This test is performed to find out the integrity of
capsule shell.
The standard capsule shells kept at the room
temperature 40 ⁰c and 80% RH becomes more
soft ,sticky and swollen .
B) DETERMINATION OF SHELF
LIFE :
Shelf life or the expiry date of packed capsules is
determined under normal storage conditions.
28
29. The invariabilty in the medicaments packed in
the
capsule shells can be determined by performing
the
following tests :
a) Weight variation test
b) Content uniformity test
29
30. FOR HARD CAPSULES
weigh 20 capsules individually and determine the avg weight
The individual weight should be with in limit of 90-110% of avg weight
If not all of capsules fall with in the limits,
Weigh 20 capsules individually
Remove the net content of each capsule with the aid of a small brush
Weigh the empty shells individually
NET WT OF CONTENTS INDIVIDUALLY =
THE WT OF SHELL-GROSS WT
31. Determine the avg net content from the sum of individual
net weight
Then determine the difference b/w each individual net
content and avg net content
32. 10 capsules are taken and subjected to assay
9 of 10 capsules should be in the range of +_15%
(85-115%)
And 10th capsule are beyond +_ 15% range then
20 capsules are assayed
All capsules with in range of +_25% (75-125%)
CONTENT UNIFORMITY
33. Disintegration test is a method to evaluate the
rate of disintegration of solid dosage forms .
disintegration is defined as the breakdown of
solid dosage form into small particles after it is
ingested .
33
34. ▪ Dissolution test is an official method to
determine the dissolution rate of a solid dosage
form .
▪ Dissolution rate is defined as the rate at which
the drug is released into the systemic
circulation from the dosage from .
34
35. 35
a) . Apparatus -1 ( rotating basket dissolution
apparatus ) :-
▪Small wire mesh size basket – 22
▪Temperature – 37 +/- 5⁰c
▪Rotated speed – 25 -150 rpm
▪Dissolution medium hight from the
bottam of the vessel :- 23-27 mm
36. b) Apparatus -2 ( rotating paddle dissolution
apparatus) :-
Small wire mesh size :- 22
Dissolution medium hight from the
bottam of the vessel :- 23-27 mm
▪Temperature – 37 +/- 5⁰c
▪Rotated speed – 25 -150 rpm
▪Dissolution medium hight from the
36
37. To assure the suitability of containers for
packaging capsules .
The moisture permeating feature of capsules
packaged in
▪ single unit containers – blister pack or strip pack
▪ unit dose containers – glass or plastic bottles
Are to be determined .
37