quality control & gmp of vati/gutika - amam-ayurveda.org

QUALITY CONTROL & G.M.P OF VATI/GUTIKA
Presented by :-
Dr. MANOJ KUMAR DASH
M.D. (Ayurveda)
Ayurveda Expert
OTHER TEAM MEMBERS :-
Dr. Himanshu S.Tiwari Dr. Abdul Bari
M.D. (Ayurveda) M.D. (Unani)
Mr. Prabhat Verma
M.Pharma (Ayu.)

AYURVEDIC CONCEPT OF
VATI / GUTIKA
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AYURVEDIC CONCEPT OF
VATI / GUTIKA
• Vati Kalpana is the out come of kalka kalpana.
Sharangadhara has mentioned a specific
chapter for preparing Vati by specific
techniques in his Sharangadhara Samhita. Vati
(tablets), Gutika (pills) and Modaka (Large size
pills) etc. are presented as tablets or pills.
According to the Acharya Sharangadhara
Gutika, Vati, Modaka, Vatika, Pindi, Guda, Varti
(tablets, bouls, pills, draggees) are synonyms
of Vati kalpana.

AYURVEDIC CONCEPT OF
VATI / GUTIKA
• Gutika:If the medicine is rolled into small circular shape masses, s, called Gutika. This
can be compared with pills in modern pharmaceutics.
• Vati:-Vati is made in the shape of flat circular mass hence it is similar to tablet.
• Guda:-Kasthausadhi churna is mixed with Gudapaka and prepared product is called
Guda.
• Guggulu: - Kasthaushadhi churna and bhasma etc. are mixed with Guggulu and make
Vati and Gutika, known as Guggulu Kalpana.
• Varti: - If the Gutika or Vati medicine is modified into this long oval shaped solid
form, then it is called as Varti Kalpana. This is commonly used for local administration
of following routes Viz. Guda (Anus), Yoni (Vagina), Shisna (Penis), Netra (Eye).
According to the specific route of drug administration, the length and diameter of the
Varti can be modified.
• Vataka:-If medicine moulded into big circular mass form known as Vataka.
• Pinda or Pindi:-Aushadhi churna is mixed with Sarkara and medicine is moulded like
Pinda then it is called as Pinda or Pindi kalpana.
• Modaka:- It will be having circular shape and having big size usually it is prepared
with medicine possessing weight around 20 g, 50 g, 100 g of around big lemon fruit
size rolled into circular mass form then it is called Modaka.

WHAT IS G.M.P
GMP MEANS GOOD
MANUFACTURING PRACTICE
WHY IS GMP IMPORTANT
• POOR QUALITY MEDICINES - A HEALTH HAZARD
• WASTAGE OF MONEY a] CONSUMER b] GOVT.
• TO PRODUCE CONSISTENTLY A CONTROLLED
STANDARD EFFICACEIOUS PRODUCTS
• TO BOOST THE PHARMACEUTICAL EXPORTS
• TO DIMINISH THE RISKS LIKE CROSS
CONTAMINATION & MIXUPS

SOURCES OF QUALITY
4 M’S :- MATERIALS, MACHINES, METHODS & MEN
MATERIALS:-
VARIATION
1. BETWEEN SUPPLIERS OF THE SAME SUBSTANCE
2. BETWEEN BATCHES FROM SAME SUPPLIER
3. WITHIN THE BATCH
MACHINES:-
1. VARIATION OF EQUIPMENT FOR SAME PROCESS
2. DIFFERENCE IN ADJUSTMENT OF EQUIPMENT
3. DEPRICIATION AND IMPROPER MAINTAINANCE

SOURCES OF QUALITY
METHODS
1.INCORRECT PROCEDURES
2.INADEQUATE PROCEDURES
3.NEGLIGENCE BY CHANCE
MEN
IMPROPER WORKING CONDITION
INADEQUATE TRAINING
LACK OF INTEREST & EMOTIONAL
UPHEAVELS
DISONESTY,FATIGUE & CARELESSNESS

G.M.P. TO ENSURE FOR
• TO MAKE USE OF AUTHENTIC RAW MATERIALS,OF
PRESCRIBED QUALITY
• TO MAINTAIN THE PRESCRIBED MANUFACTURING
PROCESS
• TO ADOPT ADEQUATE QUALITY CONTROL MEASURES
• TO ASCERTAIN THE RELEASED DRUG FOR SALE IS OF
ACCEOPTABLE QUALITY
• TO DOCUMENT THE WHOLE PROCEDURES FOR
REFERENCE

DIFFICULTIES
MATERIAL & MACHINE
• SUPPLY FROM DIFFERENT SUPPLIERS
• SUPPLY OF DIFFERENT BATCHES OF SAME
MATERIAL FROM SINGLE SUPPLIER
• SAME PROCEDURE FOLLOWED BY USING
DIFFERENT APPARATUSES
• QUALTY EFFECTED BY THE CONDITION &
MAINTAINACE OF PLANT[MACHINERY]

DIFFICULTIES…… Contd.
METHOD
• FOLLOWING WRONG METHODS IN
MANUFACTURING
• INADEQUATE COMPLETION OF
MANUFACTUIRNG
• CO-INCIDATION & CROSS CONTAMINATION
• BY MISTAKE & NEGLIGENCE

DIFFICULTIES…… Contd.
MAN POWER
• LACK OF FECILITIES AT WORK PLACE
• INADEQUATE TRAINING & LACK OF
UNDERSATNDING OF WORKERS
• LACK OF INTEREST & WORK CULTURE
• CORRUPTION,CARELESSNESS,LACK OF
STAMINA

ANALYTICAL DATA OF
Parameters like :-
Colour
Odour
Taste
Shape
Surface
Coating
Average weight
Disintegration test
Hardness test
Friability test

PHYSICO-CHEMICAL
OF TABLETS
Loss on drying % w/w
Ash value % w/w
Acid insoluble ash w/w
Water soluble extract % w/w
Alcohol soluble extract %w/w

Qualitative Chemical test
for tablets
Test for
•Tannin
•Saponin
•Flavonoid
•Triterpenoid
•Sugar
•Alkaloid

GMP/Q.C FOR TABLETS
• An ideal tablet should be free from any visual
defect or functional defect.
• The advancements and innovations in tablet
manufacture have not decreased the problems,
often encountered in the production, instead
have increased the problems,
• Mainly because of the complexities of tablet
presses; and/or the greater demands of
quality.

GMP/Q.C FOR TABLETS CONT….
• Here, we will discuss the imperfections found in
tablets along–with their causes and related
remedies.
• The imperfections are known as: ‘VISUAL DEFECTS’
and they are either related to imperfections in any
one or more of the following factors:
• I. Tableting Process
• II. Excipient
• III. Machine

GMP/Q.C FOR TABLETS CONT….
• Capping
• ‘Capping’ is the term used, when the upper or
lower segment of the tablet separates
horizontally, either partially or completely from
the main body of a tablet and comes off as a
cap, during ejection from the tablet press, or
during subsequent handling.
• Reason: Capping is usually due to the air–
entrapment in a compact during compression,
and subsequent expansion of tablet on ejection
of a tablet from a die.

GMP/Q.C FOR TABLETS CONT….
• Lamination / Laminating
• Definition: ‘Lamination’ is the separation of a
tablet into two or more distinct horizontal
layers.
• Reason: Air–entrapment during compression
and subsequent release on ejection.
• The condition is exaggerated by higher speed
of turret

GMP/Q.C FOR TABLETS CONT….
• Chipping
• Definition: ‘Chipping’ is defined as the
breaking of tablet edges, while the tablet
leaves the press or during subsequent handling
and coating operations.
• Reason: Incorrect machine settings, specially
mis-set set ejection take-off.

GMP/Q.C FOR TABLETS CONT….
• Cracking
• Definition: Small, fine cracks observed on the
upper and lower central surface of tablets, or
very rarely on the sidewall are referred to as
‘Cracks’.
• Reason: It is observed as a result of rapid
expansion of tablets, especially when deep
concave punches are used.

GMP/Q.C FOR TABLETS CONT….
• Sticking / Filming
• Definition: ‘Sticking’ refers to the tablet
material adhering to the die wall.
• Filming is a slow form of sticking and is largely
due to excess moisture in the granulation.
• Reason: Improperly dried or improperly
lubricated granules.

GMP/Q.C FOR TABLETS CONT….
• Picking
• Definition: ‘Picking’ is the term used when a small
amount of material from a tablet is sticking to and
being removed off from the tablet-surface by a
punch face.
• The problem is more prevalent on the upper punch
faces than on the lower ones. The problem worsens,
if tablets are repeatedly manufactured in this station
of tooling because of the more and more material
getting added to the already stuck material on the
punch face.
• Reason: Picking is of particular concern when punch
tips have engraving or embossing letters, as well as
the granular material is improperly dried.

GMP/Q.C FOR TABLETS CONT….
• Binding
• Definition: ‘Binding’ in the die, is the term
used when the tablets adhere, seize or tear in
the die. A film is formed in the die and ejection
of tablet is hindered. With excessive binding,
the tablet sides are cracked and it may crumble
apart.
• Reason: Binding is usually due to excessive
amount of moisture in granules, lack of
lubrication and/or use of worn dies.

GMP/Q.C FOR TABLETS CONT….
• Mottling
• Definition: ‘Mottling’ is the term used to
describe an unequal distribution of colour on a
tablet, with light or dark spots standing out in
an otherwise uniform surface.
• Reason: One cause of mottling may be a
coloured drug, whose colour differs from the
colour of excipients used for granulation of a
tablet.

GMP/Q.C FOR TABLETS CONT….
• Double impression
• Definition: ‘Double Impression’ involves only those
punches, which have a monogram or other
engraving on them.
• Reason: At the moment of compression, the tablet
receives the imprint of the punch. Now, on some
machines, the lower punch freely drops and travels
uncontrolled for a short distance before riding up the
ejection cam to push the tablet out of the die, now
during this free travel, the punch rotates and at this
point, the punch may make a new impression on the
bottom of the tablet, resulting in ‘Double
Impression’.
• If the upper punch is uncontrolled, it can rotate
during the short travel to the final compression stage
and create a double impression.

GMP/Q.C FOR TABLETS CONT….
• Blistering
• Definition: It is local detachment of film
from the substrate forming blister.
• Reason: Entrapment of gases in or
underneath the film due to overheating
either during spraying or at the end of the
coating run.

GMP/Q.C FOR TABLETS CONT….
• Chipping
• Definition: It is defect where the film
becomes chipped and dented, usually at
the edges of the tablet.
• Reason: Decrease in fluidizing air or speed
of rotation of the drum in pan coating.

GMP/Q.C FOR TABLETS CONT….
• Cratering
• Definition: It is defect of film coating whereby
volcanic-like like craters appears exposing the
tablet surface.
• Reason: The coating solution penetrates the
surface of the tablet, often at the crown where
the surface is more porous, causing localized
disintegration of the core and disruption of the
coating.

GMP/Q.C FOR TABLETS CONT….
• Picking
• Definition: It is defect where isolated areas of
film are pulled away from the surface when the
tablet sticks together and then part.
• Reason: Conditions similar to cratering that
produces an overly wet tablet bed where
adjacent tablets can stick together and then
break apart.

GMP/Q.C FOR TABLETS CONT….
• Pitting
• Definition: It is defect whereby pits
occur in the surface of a tablet core
without any visible disruption of the film
coating.
• Reason: Temperature of the tablet core is
greater than the melting point of the
materials used in the tablet formulation.

GMP/Q.C FOR TABLETS CONT….
• Blooming
• Definition: It is defect where coating
becomes dull immediately or after
prolonged storage at high temperatures.
• Reason: It is due to collection on the
surface of low molecular weight
ingredients included in the coating
formulation. In most circumstances the
ingredient will be plasticizer.

GMP/Q.C FOR TABLETS CONT….
• Blushing
• Definition: It is defect best described as
whitish specks or haziness in the film.
• Reason: It is thought to be due to
precipitated polymer exacerbated by the
use of high coating temperature at or
above the thermal gelation temperature of
the polymers.

GMP/Q.C FOR TABLETS CONT….
• Colour variation
• Definition: A defect which involves
variation in colour of the film.
• Reason: Alteration of the frequency and
duration of appearance of tablets in the
spray zone or the size/shape of the spray
zone.

GMP/Q.C FOR TABLETS CONT….
• Infilling
• Definition: It is defect that renders the intagliations
indistinctness.
• Reason: Inability of foam, formed by air spraying of
a polymer solution, to break. The foam droplets on
the surface of the tablet breakdown readily due to
attrition but the intagliations form a protected area
allowing the foam to accumulate and “set”. Once the
foam has accumulated to a level approaching the
outer contour of the tablet surface, normal attrition
can occur allowing the structure to be covered with a
continuous film.

GMP/Q.C FOR TABLETS CONT….
• Orange peel/Roughness
• Definition: It is surface defect
resulting in the film being rough and
nonglossy. Appearance is similar to
that of an orange.
• Reason: Inadequate spreading of the
coating solution before drying.

GMP/Q.C FOR TABLETS CONT…..
• Cracking/Splitting
• Definition: It is defect in which the film either
cracks across the crown of the tablet (cracking)
or splits around the edges of the tablet
(Splitting)
• Reason: Internal stress in the film exceeds
tensile strength of the film.