Serial Name of the Experiment Page Date

Number
01 Determination of Wall thickness, 1-2
Diameter, Emptyjoined length of Empty
Hard Gelatin (EHG) Capsules.
02 Determination of Integrity, GSM and 3-5
thickness of Aluminium foil.

03 Preparation of Metronidazole tablet using 6-9

dry granulation (slugging) method.
04 Preparation Paracetamol tablets using 10-12
direct compression method.
05 Preparation of Vitamin C Effervescent 13-15
tablet using wet granulation method.
06 Preparation of paracetamol orally 16-18
disintegrating tablet (ODT).
07 Preparation of Mannitol 10% Injection. 19-22
08 Preparation of Dextrose 5% Injection 23-26
09 Preparation of Vitamin B Complex 27-30
Capsule.

Number of the experiment: 01

 Advanced Pharmaceutical Manufacturing Technology Lab

Name of the experiment: Determination of Wall thickness, Diameter, Empty joined length of
Empty Hard Gelatin (EHG) Capsules.
Date of the experiment:

Objective:
To determination of length, Diameter, Wall thickness, and Empty joined length of E.H. Gelatin
capsule.
Apparatus required:
 Vernier scale,
 Slide calipers,
 Normal scale,
 N.T. Cutter.
Material required:
Empty Hard Gelatin Capsules
Procedure:
1. Randomly 3 empty capsules were collected.
2. Body and cap manually separated.
3. Take individual length, diameter and thickness of body and cap of the above sample was taken
and joined length of the capsule using Vernier scale.
4. Determine the average Length of Empty capsules, Body and cap.
5. Determine the average Diameter and wall thickness of Body and cap.

Table:

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Length of Empty Capsule:

Length (cm) Average Length (cm)

Capsule

Length, diameter and thickness of Body and Cap:

Length Average Diameter Average Thickness Average

(cm) Length (cm) Diameter (mm) Thickness
(cm) (cm) (mm)

Body

Cap

Precaution:
 Capsules should be handled gently during measurement and use surgical gloves.
 Room temperature and R.H. should be NMT25°Cand NMT50% respectively.

Number of the experiment: 02

Name of the experiment: Determination of Integrity and thickness of Aluminium foil.
Date of the experiment:

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Objective:

To evaluate the integrity and thickness of the blister aluminium foil. To evaluate the blister
aluminium foil.

Apparatus required:

 Vernier scale,
 Weight Balance,
 NT cutter,
 Scissors,
 Beaker.

Reagent required:

 Sodium Hydroxide.

Material required:

 Aluminium foil

Method:

Determination of Thickness:

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1. Cut the foil 3 strips with the scissors.

2. Measure the thickness of these 3 strips of using Vernier scale and calculate the average
thickness.

Determination of GSM (Gram per Square meter):

1. Cut 4 cm length and 4 cm width of the foil and separate a layer from corner of the piece and
take weight of the pieces.

2. The Aluminium containing piece was kept under solution of NaOH taken in a beaker and was
waited the aluminium has disappeared from the strip remaining only polymer piece.

3. This piece in air was dried and taken its weight.

4. GSM for all the pieces and thickness as above was calculated.

Table:

Thickness of Aluminium Foil:

Thickness Average Thickness

Polymer

Average Weight of Polymer before drying:

Weight (mg) Average Weight (mg)

Polymer

Average Weight of Polymer after Drying:

Weight (mg) Average Weight (mg)

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Polymer

Calculation:

GSM (Gram per Square meter) of Aluminium Foil:

Average Weight of Polymer before drying=

Average Weight of Polymer after drying =

Average Weight of Aluminium foil= (Average Weight of Polymer before drying - Average
Weight of Polymer after drying)

Area = 4 x 4 = 16 cm2 = 0. 0016 m2

GSM = Average Weight of Aluminium foil /Area

Result: GSM was

Precaution:
 Aluminium Foils were separated carefully.
 Room temperature and R.H. should be NMT25°Cand NMT50% respectively.

Number of the experiment: 03

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Name of the Experiment: Preparation of Metronidazole tablet using dry granulation (slugging)
method.
Date of the experiment:
Objective: To prepare Metronidazole tablet using dry granulation (slugging) method

Theory:

Tablets are solid dosage forms containing medicinal substances with or without diluents and
prepared by compressing the powder or granule in a set of tableting tool.

Dry granulation (slugging) or granulation by compression is one of the dry methods which is
generally used for moisture or heat sensitive ingredients, slugging process involves blending of
powders and the compressed into soft tablets using large flat faced punches which is then
subsequently crushed into granules and recompress into final tablets.

Tablet making involves the following general steps:

 Developing and preparing the formulation
 Preparing the granules / powder mix
 Selecting appropriate tableting tool
 Compressing the granules/powder into tablet
 Dedusting the tablet
The main objective to developing a tablet formulation using direct compression is to prepare a
tablet with
 Accurate dosage
 Good bioavailability
 Ease of compression and production
 Stability and Elegance
Following three factors should be considered for granule / powder properties:
 Good flow (using free flowing diluents and glidant)
 No adhesion (using lubricant)
 Cohesion(using directly compressible diluents)

Material required:

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API:
 Metronidazole
Excipients:
 Microcrystalline cellulose,
 Sodium starch glycolate,
 Povidone K-30,
 Talc
 Magnesium stearate.
Machine:
 Single punch tablet compression machine,
 Tumbler mixer.
Miscellaneous item required:
 Weighing scale,
 st.st. mesh,
 clean surgical gloves,
 Face mask and cap.
Procedure: Process flow chart of Metronidazole tablet (Slugging method)
Weighing
↓
Sieving/ Milling
↓
Dry powder mixing
↓
Slugging
↓
Sieving/ Milling
↓
Lubrication
↓
Compression
Preparation of powder mix:

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1. Weigh the entire ingredient and check them following pilot copilot system.
2. Pass metronidazole, Povidone K-30, Talc and microcrystalline cellulose (PH101) mesh#20.
3. Mix all dry powder.
4. Make slug of dry powder.
5. Pass magnesium stearate and Sodium starch glycolate through mesh # 60.
6. Mix the entire ingredient in a tumble mixer.
7. Add the lubricated powder.
8. Compress the powder into tablet using 13.2 mm round, flat beveled punch in a single station.
Typical formula for Metronidazole tablet 400 mg:

Each tablet contains:

Ingredient Amount (mg)

Metronidazole 400
Microcrystalline cellulose 480
Povidone K-30 20
Talc 5
Sodium starch glycolate 20
Magnesium stearate 5

Table:
Initial weight Average initial Weight after Average weight
weight (I) friability after friability (F)
Metronidazole

Calculation:

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I =Initial weight of tablets,

F = weight after friability.
Friability = (I-F).100/I
=
=
Result:
Friability was
Hardness was

Precaution:
 Room temp-NMT 25 degree centigrade and relative humidity -NMT 50%
 Machine cleanliness and set up is appropriate
 Use clean surgical gloves, cap and face mask.

Number of the experiment: 04

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Name of the Experiment: Preparation Paracetamol tablets using direct compression method.
Date of the experiment:
Objective: To prepare paracetamol tablets using direct compression method.
Theory:
Tablets are solid dosage forms containing medicinal substances with or without suitable diluents
and prepared by compressing the powder or granule in a set of tableting tool.
Direct compression method involves the direct compaction of tableting mixture without the step
of granulation, provided the tableting mixture should have enough flow properties and should
form tablet.
Tablet making involves the following general steps:
 Developing and preparing the formulation
 Preparing the granules / powder mix
 Selecting appropriate tableting tool
 Compressing the granules/powder into tablet
 Dedusting the tablet
The main objective to developing a tablet formulation using direct compression is to prepare a
tablet with
 Accurate dosage
 Good bioavailability
 Ease of compression and production
 Stability and Elegance
Following three factors should be considered for granule / powder properties:
 Good flow (using free flowing diluents and glidant)
 No adhesion (using lubricant)
 Cohesion(using directly compressible diluents)
Material required:
API:
 Paracetamol

Excipients:

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 Advanced Pharmaceutical Manufacturing Technology Lab

 Microcrystalline cellulose,
 Sodium starch glycolate,
 Magnesium stearate.
Machine:
 Single punch tablet compression machine,
 Tumbler mixer.
Miscellaneous item required:
 Weighing scale,
 St.st. mesh,
 Clean surgical gloves,
 Face mask and cap.
Procedure:
Process flow chart of paracetamol tablet (direct compression method)
Weighing
↓
Sieving/ Milling
↓
Mixing /Lubrication
↓
Compression
Preparation of powder mix:
1. Weigh the entire ingredient and check them following pilot copilot system.
2. Pass paracetamol and microcrystalline cellulose (PH101) through st.st. Mesh#20.
3. Pass magnesium stearate and Sodium starch glycolate through mesh # 60.
4. Mix the entire ingredient in a tumble mixer.
5. Add the lubricated powder.
6. Compress the powder into tablet using 13.2 mm round, flat beveled punch in a single station.

Typical formula for Paracetamol tablet 325 mg:

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 Advanced Pharmaceutical Manufacturing Technology Lab

Each tablet contains:

Ingredient Amount (mg)
Paracetamol 325
Microcrystalline cellulose 465
Sodium starch glycolate 5
Magnesium stearate 5

Table:
Initial weight Average initial Weight after Average weight
weight (I) friability after friability (F)
Paracetamol

Calculation:
I =Initial weight of tablets,
F = weight after friability.
Friability = (I-F).100/I
=
=
Result:
Friability was
Hardness was
Precaution:
 Room temp-NMT 25 degree centigrade and relative humidity -NMT 50%.
 Machine cleanliness and set up is appropriate.
 Use clean surgical gloves, cap and face mask.

Number of the experiment: 05

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 Advanced Pharmaceutical Manufacturing Technology Lab

Name of the Experiment: Preparation of Vitamin C Effervescent tablet using wet granulation
method.
Date of the experiment:
Objective: To prepare Vitamin C Effervescent tablet using granulation method.
Theory:
Effervescent tablet is a tablet intended to be dissolved or dispersed in water before
administration. Effervescent tablets are uncoated tablets that generally contain acid substances
and carbonates or bicarbonates and which react rapidly in the presence of water by releasing
carbon dioxide. Effervescent is the reaction of acids and bases producing carbon dioxide in
water. Typical acids used in this reaction are citric, malic, tartaric and fumaric. Citric acid is the
most commonly used, and it imparts a citrus like taste to the product. Malic acid can be used in
effervescent formulas for smooth aftertaste, but the price of malic acid is higher than that of
citric acid. Tartaric and fumaric acids are used sparingly because of their low water solubility.
In wet granulation, granules are formed by the addition of a granulation liquid onto a powder bed
which is under the influence of an impeller, screws or air. The agitation resulting in the system
results in the aggregation of the primary powder particles to produce wet granules.
The Effervescent Reaction:
Acid + Carbonic salt —> CO2+ Acid Salt + H20
Tablet making involves the following general steps:
 Developing and preparing the formulation
 Preparing the granules / powder mix
 Selecting appropriate tableting tool
 Compressing the granules/powder into tablet
 Dedusting the tablet
The main objective to developing a tablet formulation using direct compression is to prepare a
tablet with
 Accurate dosage
 Good bioavailability
 Ease of compression and production
 Stability and Elegance
Following three factors should be considered for granule / powder properties:

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 Good flow (using free flowing diluents and glidant)

 No adhesion (using lubricant)
 Cohesion(using directly compressible diluents)
Materials and machine required:
API:
 Ascorbic acid
Excipients:
 Sucrose,
 Povidone,
 Tartaric acid,
 Sodium bi carbonate,
 Polyethylene glycol 6000,
 Orange flavor,
 Saccharine sodium,
 Methylene chloride,
 Isopropanol.
Machine:
 Single station tablet compression machine,
 Tumbler mixer.
Miscellaneous items required:
 Weighing scale,
 St. st. mesh ft 20, 40 and 60,
 Powder spreader,
 Clean surgical gloves,
 Face mask and cap,
 Clean soft towel or surgical gauge for polishing.

Preparation of powder mix:

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1. Weigh all the ingredients and check them following pilot co-pilot system.
2. Pass ascorbic acid and sucrose through st.st mesh #40 and dry 30° C for 30 minutes.
3. Pass the lubricant and glidant through mesh #60.
4. Mix sodium bi carbonate and tartaric acid for 15 minutes.
5. Dissolve povidone in isopropanol and Methylene chloride.
6. Granulate the above powder mix with povidone and dry the wet mass at 60°C for 20 min.
7. Dry screens the granule using st.st. mesh #20.
8. Mix the above granules with all other ingredients including lubricants.
9. Compress the powder into tablet using 13.2 mm round, flat beveled punch in a single station.
Formulation of Vitamin C 250 mg tablet:
Each tablet contains:
Ingredient Amount
Ascorbic Acid 250 mg
Sodium bicarbonate 250 mg
Tartaric Acid 200 mg
Povidone k- 30 4.0mg
Isopropanol 0.075ml
Methylene chloride 0.075 ml
sucrose 330.5mg
Polyethylene glycol 6000 33.5 mg
micronized
Orange flavor powder 5mg
Saccharin sodium 0.5mg

Precaution:
 Room temp- NMT 25 degree Celsius and Rel. Humidity - 35%
 Machine cleanliness and set up is appropriate
 Use clean and polishing tableting tool
 Use clean surgical gloves, cap and face mask
Number of the experiment: 06
Name of the Experiment: Preparation of paracetamol orally disintegrating tablet (ODT).

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Date of the experiment:

Objective: To prepare paracetamol orally disintegrating tablet using wet granulation method.
Theory:
ODT is a solid-dosage form that disintegrates and dissolves in the mouth without water within 60
seconds or less.
According to USFDA ‘it is a solid dosage form containing medicinal substances, which
disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.’
Mechanism of ODT drugs:
Generally, ODTs are formulated to disperse rapidly in the mouth, enabling medication to be
swallowed without water, thereby increasing convenience and compliance across a broad range
of indications and patient types of young, elderly and active patients.
Tablet making involves the following general steps:
 Developing and preparing the formulation
 Preparing the granules / powder mix
 Selecting appropriate tableting tool
 Compressing the granules/powder into tablet
 Dedusting the tablet
The main objective to developing a tablet formulation using direct compression is to prepare a
tablet with
 Accurate dosage
 Good bioavailability
 Ease of compression and production
 Stability and Elegance
Following three factors should be considered for granule / powder properties:
 Good flow (using free flowing diluents and glidant)
 No adhesion (using lubricant)
 Cohesion(using directly compressible diluents)

Materials and machine required:

API:
 Paracetamol

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Excipients:
 Mannitol,
 Eydragit E 100,
 Crospovidone
 Colloidal Silicon Dioxide,
 Magnesium Stearate,
 Aspartame,
 Orange flavor,
 Ethanol.
Machine:
 Single station tablet compression machine,
 Tumbler mixer.
Miscellaneous items required:
 Weighing scale,
 St. st. mesh ft 20, 40 and 60,
 Powder spreader,
 Clean surgical gloves,
 Face mask and cap,
 Clean soft towel or surgical gauge for polishing.
Preparation of powder mix:
1. Weigh all the ingredients and check them following pilot co-pilot system.
2. Prepare Eydragit E 100 in Ethanol.
3. Pass the lubricant and glidant through mesh #60.
4. Mix Paracetamol, half of mannitol, half of crospovidone and Aspartame for 15 minutes.
5. Granulate the above powder mix with Eydragit E 100 solution.
6. Dry the wet mass at 60°C for 20 min.
7. Dry screens the granule using st.st. mesh #20.
8. Mix the remaining half of mannitol and crospovidone and flavor with the above granule and
lubricate for 5 minutes.
9. Compress the powder into tablet using 13.2 mm round, flat beveled punch in a single station.
Formulation of Paracetamol ODT 250 mg tablet:

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Each tablet contains:

Ingredient Amount
Paracetamol 250 mg
Mannitol 300 mg
Eydragit E 100 100 mg
Crospovidone 7.8 mg
Colloidal Silicon Dioxide 3.25 mg
Magnesium Stearate 3.25 mg
Aspartame 10 mg
Orange flavor powder 45 mg
Ethanol 0.25ml

Precaution:
 Room temp- NMT 25 degree Celsius and Rel. Humidity - 35%
 Machine cleanliness and set up is appropriate
 Use clean and polishing tableting tool
 Use clean surgical gloves, cap and face mask

Number of the experiment: 07

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 Advanced Pharmaceutical Manufacturing Technology Lab

Name of the Experiment: Preparation of Mannitol 10% Injection.

Date of the experiment:
Objective: To preparation of Mannitol 10% injection.
Theory:
It is a sterile, non pyrogenic solution of Mannitol USP in a single dose container for intravenous
administration. It contains no antimicrobial agents.
Mannitol is a 6-carbon sugar alcohol prepared commercially by the reduction of dextrose.
Mannitol is an obligatory osmotic diuretic and pH is 5.0 (4.5-7.0).
Sterile solution making involves:
 Developing and preparing formulation
 Preparing WFI
 Selecting appropriate packaging material
 Cleaning and sterilizing the packaging material and filtration equipment’s
 Sterilizing the filled products
Equipment and glass wares required:
 Balance,
 Beaker,
 Funnel,
 Filter paper,
 Conical Flask,
 Micro filtration unit (including .22u. membrane filter),
 Autoclave,
 Laminar Air Flow bench.
Packaging material required:
25ml clear glass ample
Reagent required:
 Mannitol
 WFl (freshly prepared),
 HCI,
 NaOH.
Formula:

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 Advanced Pharmaceutical Manufacturing Technology Lab

Ingredient Amount
Mannitol 10 gm
WFI quantity sufficient to 100 ml
HCl/NaOH To adjust pH (4.5-7.0)

Sterilization of equipment:
 Wash all the glass wares, filtration equipment and other utensils needed for processing
the solution.
 Place all the items in a s.s basket and load in the autoclave.
 Sterilize the items at 121°C for 30mins.
 Unload all the items and keep in clean area.
Washing of Ampoule:
 Washing the ampoule with filtered water (.5u) and keep them in inverted position in a
tray.
 Check the clearly for the particulate matter such as glass, fiber. Other visible foreign
matter etc. for the ampoule.
Depyrogenation of washed ampoule:
 Sterilize the washed ampoule in oven at a temperature 220°C for 2hrs,
 Keep ampoules in oven until it reaches normal temperature. These ampoules are ready for
filling.
Procedure:
A. Manufacturing of solution:
1. Collect freshly prepared WFI (endotoxin passed) in a clean and dry beaker.
2. Take 80ml WFI in a beaker and add Mannitol and dissolve by stirring.
3. Make near to the volume to 100ml with WFI and check pH if needed add HCI/NaOH to
adjust pH
4. Finally make up to the volume and perform other necessary tests.
5. Filter the solution using sterilized membrane (.22u) under LAF.
6. Perform integrity test of membrane filter before and after filtration.

B. Filling and sealing of solution:

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1. Check the cleanliness of the filling area.

2. Transfer sterilized ampoule in filling area and also the filtered solution in the same area
taking in a closed container.
3. Under LAF flush filtered nitrogen into the sterile ampoule and fill the solution, and flush
nitrogen again to replace the air in head space and seal the rotating ampoule immediately using
flame (Natural gas and Oxygen).
C. Sterilization of solution in ampoule:
1. Check the cleanliness of the autoclave chamber and the water level inside.
2. Load the entire ampoule in the autoclave and close the lid of the autoclave. Ensure that the
position of the gasket is in place.
3. Sterilization of solution in ampoule at 121°C for 30mins.
4. Take out the sterilized ampoule form the autoclave after completion of sterilization process.
D. Inspection:
1. Inspect the ampoule for the presence of non-uniform dose/particulate matter such as glass,
fiber, other visible foreign matter etc.
2. Transfer the inspected ampoule in quarantine area.
E. Labeling:
 Name of the product (Generic name) with strength Composition
 Batch
 Date of Manufacturing,
 Date of Expire.
F. Storage:
The product should be stored below 30°C.
Precaution:
 Protective clothing and gloves must be worn when handling raw materials.
 The solution must be protected from light and air exposure throughout the manufacturing.
 The product must be stored in air light container.
 Processing equipment and other contact parts must be cleaned following appropriate
procedure.
 The sequences in the manufacturing process are to be strictly followed.
 WFI must be freshly prepared.

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 Temperature of the solution must not be more than 30°C during volume adjustment.

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Number of the experiment: 08

Name of the Experiment: Preparation of Dextrose 5% Injection.
Date of the experiment:
Objective: To preparation of Dextrose 5% injection.
Theory:
It is a sterile, non pyrogenic solution of Dextrose USP in a single dose container for intravenous
administration. It contains no antimicrobial agents.
Dextrose is a 6-carbon sugar alcohol. It is actually D-form of Glucose. Dextrose is an obligatory
osmotic diuretic and pH is between 3.2-6.5.
Sterile solution making involves:
 Developing and preparing formulation
 Preparing WFI
 Selecting appropriate packaging material
 Cleaning and sterilizing the packaging material and filtration equipment’s
 Sterilizing the filled products
Equipment and glass wares required:
 Balance,
 Beaker,
 Funnel,
 Filter paper,
 Conical Flask,
 Micro filtration unit (including .22u. membrane filter),
 Autoclave,
 Laminar Air Flow bench.
Packaging material required:
25ml clear glass ample
Reagent required:
 Dextrose
 WFl (freshly prepared),
 HCI,
 NaOH.

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Formula:
Ingredient Amount
Dextrose 5 gm
WFI quantity sufficient to 100 ml
HCl/NaOH To adjust pH (3.2-6.5)

Sterilization of equipment:
 Wash all the glass wares, filtration equipment and other utensils needed for processing
the solution.
 Place all the items in a s.s basket and load in the autoclave.
 Sterilize the items at 121°C for 30mins.
 Unload all the items and keep in clean area.
Washing of Ampoule:
 Washing the ampoule with filtered water (.5u) and keep them in inverted position in a
tray.
 Check the clearly for the particulate matter such as glass, fiber. Other visible foreign
matter etc. for the ampoule.
Depyrogenation of washed ampoule:
 Sterilize the washed ampoule in oven at a temperature 220°C for 2hrs,
 Keep ampoules in oven until it reaches normal temperature. These ampoules are ready for
filling.
Procedure:
A. Manufacturing of solution:
1. Collect freshly prepared WFI (endotoxin passed) in a clean and dry beaker.
2. Take 80ml WFI in a beaker and add Mannitol and dissolve by stirring.
3. Make near to the volume to 100ml with WFI and check pH if needed add HCI/NaOH to
adjust pH
4. Finally make up to the volume and perform other necessary tests.
5. Filter the solution using sterilized membrane (.22u) under LAF.
6. Perform integrity test of membrane filter before and after filtration.

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B. Filling and sealing of solution:

1. Check the cleanliness of the filling area.
2. Transfer sterilized ampoule in filling area and also the filtered solution in the same area
taking in a closed container.
3. Under LAF flush filtered nitrogen into the sterile ampoule and fill the solution, and flush
nitrogen again to replace the air in head space and seal the rotating ampoule immediately using
flame (Natural gas + Oxygen)
C. Sterilization of solution in ampoule:
1. Check the cleanliness of the autoclave chamber and the water level inside.
2. Load the entire ampoule in the autoclave and close the lid of the autoclave. Ensure that the
position of the gasket is in place.
3. Sterilization of solution in ampoule at 121°C for 30mins.
4. Take out the sterilized ampoule form the autoclave after completion of sterilization process.
D. Inspection:
1. Inspect the ampoule for the presence of non-uniform dose/particulate matter such as glass,
fiber, other visible foreign matter etc.
2. Transfer the inspected ampoule in quarantine area.
E. Labeling:
 Name of the product (Generic name) with strength Composition
 Batch
 Date of Manufacturing,
 Date of Expire.
F. Storage:
The product should be stored below 30°C.
Precaution:
 Protective clothing and gloves must be worn when handling raw materials.
 The solution must be protected from light and air exposure throughout the manufacturing.
 The product must be stored in air light container.
 Processing equipment and other contact parts must be cleaned following appropriate
procedure.
 The sequences in the manufacturing process are to be strictly followed.

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 WFI must be freshly prepared.

 Temperature of the solution must not be more than 30°C during volume adjustment.

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Number of the experiment: 09

Name of the Experiment: Preparation of Vitamin B Complex Capsule.
Date of the experiment:
Objective: To prepare Vitamin B Complex Capsule.
Theory:
Capsules are solid dosages form in which medicaments and/or insert substances are enclosed in a
small hard shell of gelatin. The hard capsule shell consists of two pieces in the form of cylinder
closed at one end, the shorter piece called the ‘cap’ fits over the open end of the longer piece,
called the ‘body’.

Thiamine Mononitrate Riboflavin

Pyridoxine Hydrochloride Nicotinamide

Encapsulation of hard gelatin capsule is divided into the following steps:

 Developing and preparing the formulation.
 Selecting the empty hard gelatin capsule size.
 Filling the empty capsule shell.
 Cleaning and polishing the filled capsule.
The main objective to developing a capsule formulation is to prepare a capsule with
 Accurate dosage
 Good bioavailability
 Ease of filling and production
 Stability and Elegance

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Following three factors should be considered for filling properties:

 Good flow (using free flowing diluents and glidant)
 No adhesion (using lubricant)
 Cohesion(using directly compressible diluents)

Formulation of Vitamin B Complex Capsule:

Each Capsule contains:
Ingredients Specification Qty/Cap Overage

Active Ph. Ingredients

Thiamin mononitrate BP/USP 5.0 mg 2.5%
Riboflavin BP/USP 2.0 mg 2.5%
Pyridoxine hydrochloride BP/USP 2.0 mg 2.5%
Nicotinamide BP/USP 20.0 mg 2.5%
Excipients
Maize starch (Dried) BP/USP 185.0 mg
Lactose Monohydrate(Dried) BP/USP 100.0 mg
Magnesium Stearate BP/USP 6.0 mg
E.H.G. Capsule #2 Pharma Grade 1 Piece

Materials and machine required:

API:
Thiamin mononitrate, Riboflavin, Pyridoxine hydrochloride, Nicotinamide
Excipients:
 Maize starch (Dried),
 Lactose Monohydrate(Dried),
 Magnesium Stearate,
 E.H.G. Capsule #2.
Machine:
 Manual Capsule filling machine,
 Tumbler mixer.

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Miscellaneous items required:

 Weighing scale,
 S.S. mesh # 40 and 60,
 Powder spreader,
 Clean surgical gloves,
 Face mask and cap,
 Clean soft towel or surgical gauge for polishing.

Preparation of powder mix:

1. Weigh all the ingredients and check them following pilot co-pilot system.
2. Pass all the vitamin and diluents through S.S mesh #40.
3. Pass the lubricant and glidant through mesh #60.
4. Mix all the ingredients in atumble mixer.

Encapsulation:
Encapsule the powder mix into E.H.G capsule #2 using manual capsule filling mahine according
to the following steps,
I. Fill the loading tray over the bed of the filling machine.
II. Place the loading tray over the bed of the filling machine.
III. Lock the body of the capsule by operating the capsule. Separate the cap in the loading
tray itself which is then removed by operating lever.
IV. Place the weighed amount of powder mix to be filled into the capsules on the powder tray
already kept on the position over the bed.
V. Spread the powder with with the help of a powder spreader so as to fill the bodies of the
capsule uniformity.
VI. Collect Excess of the powder on the platform of the powder tray.
VII. Lower the pin plate and move it down down ward so as to press the powder into the
bodies.
VIII. Remove the powder tray and place the caps holding tray in position.
IX. Press the capsule with the help of plate with rubber top and operate the lever to unlock
the cap and body of the capsule.

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X. Remove the loading tray and and collect the filled capsule in a tray.

Polishing:
 Polish the capsule using clean soft towel or surgical gauge.

Packaging:
 Packed the filled capsule in air tight container (PE, PVC, and PVDC).

Reconciliation:
 Calculate the yield of the product.

Storage:
 Store the capsule in a cool and dry place away from sunlight.

Precaution:
 Room temp- NMT 250c and Rel. Humidity -NMT 45%
 Machine cleanliness and set up is appropriate
 Use clean and polished tool
 Use clean surgical gloves, cap and face mask

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