Q: Chọn 1 API có dạng bào chế viên nén, tham khảo patent của API, viết report j j đó,

làm PP
Thuyết trình, mỗi nhóm 15p
Ngày TT: T4, 13/3/2024
Amoxicillin
MỤC LỤC
1. Mô tả & thành phần
Huhuhuhuhuhuhuhuhuhuhuhuhuhuhuhuhhuhuuhuhuuhuhhuhuhhuhuuhuhhuuhuhuhuh
uhuhuhuhuhuhuhhuhuuhhuhuhuhuhuhuhuhuhuhuhuhuhuhuhuhuhhuuhhuuhuhuhuhhh
● Mô tả sản phẩm: The tablets are white or off/white 22 mm by 10mm oblong shaped
tablets with one score-line on both sides./
● Dạng bào chế: Dispersible tablet.
Definition: Dispersible tablets are uncoated or film-coated tablets intended to be
dispersed in water before administration, giving a homogeneous dispersion.
● Thành phần:
No Material Name Formula for 1 Specification Function
tablet

1 Amoxicillin trihydrate 1148 mg USP API

2 Avicel PH 102 500mg USP Diluent

3 Crospovidone 36mg USP Disintegrant

4 Magnesium stearate 50mg USP Lubricant

5 Aspartame 18mg VP Sweetening agent

6 Strawberry flavor 18mg Standard Flavor

manufacturer

TOTAL WEIGHT 1788 mg

Note: Not appear in finished product because of evaporating in manufacturing process.

2. Pharmaceutical development
2.1. Information on development studies
We proposed formulation of the finished product has the same qualitative and quantitative
composition with regard to the active substance, and the same pharmaceutical form as the
reference medicinal product.
To start with, the quality target product profile (QTPP) was defined by taking into consideration
of the drug substance properties, product characterization, label of the reference product and
intended patient population
*** Pharmaco-dynamic and pharmacology characterization of API
* Mechanism of action
Amoxicillin is a semisynthetic penicillin that works by inhibiting bacterial cell wall synthesis. It is
susceptible to penicillinase and is effective against gram-positive and gram-negative organisms
but is not active against beta-lactamase-producing organisms. Amoxicilline exhibits bactericidal
(kills microorganisms) action against susceptible organisms (bacteria cannot grow in the
presence of the drug) during their active multiplication phase. Amoxicilline's mode of action is
similar to ampicillin, and it therefore works by preventing the synthesis of mucopeptide (a type of
protein responsible for bacterial growth) found in the cell wall, leading to bacterial death.
* Pharmacodynamic effects
Amoxicillin competitively inhibits penicillin-binding proteins, leading to upregulation of autolytic
enzymes and inhibition of cell wall synthesis. Amoxicillin has a long duration of action as it is
usually given twice daily. Amoxicillin has a wide therapeutic range, as mild overdoses are not
associated with significant toxicity.
*Pharmacokinetic properties
1) Absorption
The drug is well absorbed from the gastrointestinal tract and is not affected by gastric acid. Food
does not affect the absorption of the drug.
2) Distribution
Distributed to all tissues and fluids in the body, it crosses the blood-brain barrier only in cases of
meningitis.
3) Biotransformation
A portion of the active ingredient is metabolized to penicilloic acid. Penicilloic acid does not have
antibacterial activity.
4) Elimination
The main route of elimination is via the urine, with a half-life of approximately 1 hour. In patients
with renal impairment, neonates, or the elderly, the half-life of the drug is prolonged.
3. Characterization of reference product
This product was evaluated and investigated according to Amoxi Almus 1g product which
descriptions are presented in below tablet.

No. Attribute Criteria

1 Reference product name Amoxi almus 1g

2 Dosage form Dispersible tablets

3 Shape The tablets are 22 mm by 10 mm oblong

Size shaped tablets with one score-line on both
sides.

4 Color White or off/white

5 Flavor Strawberry

6 Dosage Amoxicillin 1g

7 Inactive ingredients magnesium stearate, cellulose

 microcrystalline, crospovidone, strawberry
flavor and aspartame (E951)

8 Packaging The tablets are packed in blisters of

PVC/PVDC/Aluminium or
PVC/TE/PVDC/Aluminium.

9 Storage condition Do not store above 25°C. Store in the

original package in order to protect from
moisture.

10 Expire Date …

Reference:
Patient Information Leaflet for Amoxi Amus 1g.

4. Thành phần sản phẩm nghiên cứu

a. Hoạt chất
b. Tương kỵ của API với tá dược
c. Tá dược
5. Thành phẩm
*Chú ý: Tiêu chuẩn kỹ thuật cho lô prototype
6. Thử nghiệm
Mô tả quy trình
Báo cáo kết quả (làm bảng nhưng để trống đợi làm thực hành điền zô)
7. Kết quả ổn định lô quy mô phòng thí nghiệm

→ NHỮNG THỨ PHẢI LÀM:

I. MỤC LỤC
II. CANVA THUYẾT TRÌNH
III. WORD

—----------------------------
API: Amoxicillin
Nguồn them khẻo:
https://www.usp-pqm.org/sites/default/files/pqms/article/amoxicillin-pir-jul2018.pdf
https://eureka.patsnap.com/patent-CN108653224A
https://www.ghsupplychain.org/sites/default/files/2022-11/MNCH%20Commodities%20Procurem
ent-Amoxicillin.pdf
https://www.pharmacompass.com/active-pharmaceutical-ingredients/amoxicillin/drug-product-co
mposition
Khuyến cáo của UNICEF:
https://www.unicef.org/supply/media/511/file/amoxicillin-dispersible-tablets-market-and-supply-u
pdate.pdf
Thuốc đối chiếu: https://www.medicines.org.uk/emc/files/pil.11433.pdf
4. Thành phần của sản phẩm nghiên cứu
4.1. Drug substance:
Amoxicillin trihydrate

Description White to Light Yellow to Light Beige

CAS registry number 61336-70-7

Molecular formula C16H25N3O8S

Molecular weight 419.5 g/mol

Solubility 0.958 mg/mL

Melting point 193 - 203oC

IUPAC name (2S,5R,6R)-6-[[(2R)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-

dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic
acid;trihydrate

ATC code J01CA04

Reference https://pubchem.ncbi.nlm.nih.gov/compound/Amoxicillin-Trihydrate

4.2 Compatibility of the AIP with excipients

Compatibility of the active ingredient with excipients are not performed but almost excipients
were chosen based on literature/reference product Amoxi Almus 1g and the compatibility of the
active ingredient with excipients will be evaluated based on the stability date of finished
product-Lab scale batch.
4.3 Excipients
Table. List of excipients and their proposed function for AMOXI ALMUS 1g DISP. TABS

Reference drug Function Product of (gợi ý)

Amoxi almus 1g Disp tabs amoxicillin 1g

Cellulose microcrystalline Diluent Avicel PH 101

Crospovidone Disintegrant Crospovidone

Magnesium stearate Lubricant Magnesium stearate

 Aspartame (E951) Sweetening agent Aspartame

Strawberry flavor (Maize Flavor Strawberry flavor

maltodextrin, Triethyl citrate,
Flavouring components, Benzyl
alcohol, Propylene glycol)

● Microcrystalline cellulose:
Applications:
Microcrystalline cellulose is widely used in pharmaceuticals, primarily as a binder/diluent in oral
tablet and capsule formulations where it is used in both wet-granulation and direct compression
processes. In addition to its use as a binder/diluent, micro-crystalline cellulose also has some
lubricant and disintegrant properties that make it useful in tableting.
Incompatibilities:
Microcrystalline cellulose is incompatible with strong oxidizing agents.
● Crospovidone:
Applications:
Crospovidone is a water-insoluble tablet disintegrant and dissolution agent used at 2–5%
concentration in tablets prepared by direct compression or wet- and dry - granulation methods. It
rapidly exhibits high capillary activity and pronounced hydration capacity, with little tendency to
form gels.
Incompatibilities
Crospovidone is compatible with most organic and inorganic pharmaceutical ingredients. When
exposed to a high water level, crospovidone may form molecular adducts with some materials.
● Magnesium stearate
Applications:
Magnesium stearate is widely used in cosmetics, foods, and pharmaceutical formulations. It is
primarily used as a lubricant in capsule and tablet manufacture at concentrations between
0.25% and 5.0% w/w. It is also used in barrier creams.
Incompatibilities:
Incompatible with strong acids, alkalis, and iron salts. Avoid mixing with strong oxidizing
materials. Magnesium stearate cannot be used in products containing aspirin, some vitamins,
and most alkaloidal salts.
● Aspartame (E951):
 Applications:
Aspartame is used as an intense sweetening agent in beverage products, food products, and
table-top sweeteners, and in pharmaceutical preparations including tablets, powder mixes, and
vitamin preparations. It enhances flavor systems and can be used to mask some unpleasant
taste characteristics; the approximate sweetening power is 180–200 times that of sucrose.
Incompatibilities:
Differential scanning calorimetry experiments with some directly compressible tablet excipients
suggests that aspartame is incompatible with dibasic calcium phosphate and also with the
lubricant magnesium stearate. Reactions between aspartame and sugar alcohols are also
known.
● Strawberry flavor:
Contains maize maltodextrin, triethyl citrate, flavoring components, propylene glycol
and benzyl alcohol.
 5. Finish product
5. 1 . Formulation development
A. Objective
The objective was to obtain tablets with an absorption rate allowing a rapid onset of action, with
good stability properties, and of reproducible quality at commercial scale.
B. Development plan
The aim of the formulation development was to develop generic version with acceptable
physicochemical properties, stability, and ease of manufacture. The generic product was
developed in reference AMOXI ALMUS 1g DISP. TABS (Manufactured by Almus
Pharmaceuticals Ltd )
C. Tentative specifications for prototype product development
The following tentative specifications were proposed for the development of product based on
innovator characterization and Tabellae Amoxicillin - Vietnam Pharmacopeia 5.

No Parameter Specification Analytical Method

1. Appearance Oblong shaped tablet, white or off-white VP <80>

color. Solid pellets.

2. Disintegration Within 3 min in water at ± 25oC VP5 <11.6>

Time

3. Uniformity of Mean ± 5% VP5 PL 11.3

mass

4. Dissolution Not less than 80% (Q) of the amount of VP5 <80>
Amoxicillin of the amount stated above
must be dissolved in 60 min.

5. Assay 90.0 % to 120.0 % of the amount stated VP5 <80>

on the label.

6. Water Not more than 13.0 % VP5 <80>

Use about 0.15 g of pellets.

7. Friability 0,5 - 1% USP

8. Uniformity of Add 2 tablets to 100 ml of water, stir until VP <80>

dispersion completely dispersed. Dispersion is
satisfactory when the dispersion solution
flows completely through the sieve hole
with sieve size 710 μm.
From the literature search and the innovator characterization details, The formulas and trial
are conducted as below:

Trial 01:

Batch size: 100 tablets

No Name of raw material mg/tablet Batch (g) %

1 Amoxicillin trihydrate 1148 114,8 65

2 Avicel PH 102 500 50 28

3 Crospovidone 36 3,6 2

4 Magnesium stearate 50 5 3

5 Aspartame 18 1,8 1

6 Strawberry flavor 18 1,8 1

Tablet 1770 177

- Process:

Step Description

1. Pulverize raw material.

2. Pass Amoxicillin trihydrate through 30 mesh (600 μm)

Avicel PH 101, Crospovidone, Aspartame, Strawberry through 40 mesh (430 μm)
.[1,2]
3. The sifted and milled Amoxicillin trihydrate fractions were mixed in a blender for 5
minutes [2]

4. Sifted Avicel PH 101, Crospovidone, Aspartame, Strawberry were added into

blender, mix for 10 minutes [2]

5. Pass Magnesium stearate through 60 mesh (250 μm), then added to the blender,
mix for 5 minutes [1,2]

6. Compress final mixing granule.

Result:

Batch No: Trial 01 (100 tablets)

No Parameter Specification Result

1. Disintegration Within 3 min in water at ± 25oC Conduct the test with 6 tablets on
Time 2 test tube racks installed in
parallel or repeat the test on 1 test
tube rack. Place one tablet in
each test tube. Suspend the test
tube holder in a beaker containing
the specified medium maintained
at (37 ± 2) °C and operate the
instrument for the specified time.
Remove the test tube holder from
the liquid and observe the test
preparation. The test sample
meets the requirements if all 6
tablets disintegrate.

2. Uniformity of Mean ± 5% Weigh individually 20 units taken

mass at random or, for single-dose
preparations presented in
individual containers, the contents
of 20 units, and determine the
average mass. Not more than 2 of
the individual masses deviate
from the average mass by more
than the percentage deviation
shown in Table 2.9.5.-1 and none
deviates by more than twice that
percentage.
3. Dissolution Not less than 80% (Q) of the amount of
Amoxicillin of the amount stated above
must be dissolved in 60 min.
4 Assay 90.0 % to 120.0 % of the amount stated
on the label.
Take an amount of solution, filter,
discard the first 10 ml of filtrate,
and dilute if necessary. Measure
the absorbance at the maximum
wavelength of about 272 nm
(Appendix 4.1), in a 1 cm thick
measuring cup, the blank sample
is water. Compare with standard
amoxicillin trihydrate solution in
water of equivalent concentration.
Calculate the content of
amoxicillin.
Solution A: Dissolve 13.6 g
potassium dihydrophosphate (TT)
in 2000 ml water, adjust to pH 5.0
± 0.1 with 45% potassium
hydroxide solution.
Mobile phase: Solution A –
acetonitrile (96:4). Adjust the
acetonitrile ratio to achieve the
required chromatographic
conditions (if necessary).
Standard solution: Mix standard
amoxicillin trihydrate in solution A
to have an accurate amoxicillin
concentration of about 1.2 mg/ml
(use within 6 hours only).
Test solution: Weigh 20 tablets,
calculate average weight, grind
into fine powder. Accurately weigh
a quantity of pellets corresponding
to about 0.2 g of amoxicillin into a
200 ml volumetric flask, add
solution A, shake ultrasonic to
dissolve, add to volume with the
same solvent, mix well and filter
through a membrane. filter with a
pore size of no more than 1 pm
(only used within 6 hours).
Chromatographic conditions
Column size (25 cm X 4 mm) is
packed with stationary phase c(3
µm to 10 µm).
Ultraviolet spectroscopy detector
 set at 230 nm wavelength.
Flow rate: 1.5 ml/min.
Injection volume: 10 µl.
How to proceed:
Check the suitability of the
system: Inject the standard
solution, calculated based on the
main peak obtained in the
chromatogram: the capacity factor
must be between 1.1 and 2.8; The
theoretical number of plates of the
column is not less than 1700; The
symmetry factor is not greater
than 2.5 and the relative standard
deviation of the peak areas from 6
replicate injections of the standard
sample is not greater than 2.0%.
Inject test solution and standard
solution separately.
Calculate the amoxicillin content,
C16H19N305S, in the tablet from
the peak areas in the
chromatograms of the standard
and test solutions and the
C16H19N305S content in the
standard amoxicillin trihydrate.

5. Water Not more than 13.0 % VP5 <80>

Use about 0.15 g of pellets.

6. Friability 0,5 - 1% Take a sample of 10 whole

tablets. The tablets should be
carefully dedusted prior to testing.
Accurately weigh the tablet
sample, and place the tablets in
the drum. Rotate the drum 100
times, and remove the tablets.
Remove any loose dust from the
tablets as before, and accurately
weigh.

7. Uniformity of Add 2 tablets to 100 ml of water, stir until VP <80>

dispersion completely dispersed. Dispersion is
satisfactory when the dispersion solution
flows completely through the sieve hole
with sieve size 710 μm.

Trial 02: Investigation of disintegrants

Batch size: 100 tablets

Batch size: 100 tablets

No Name of raw material mg/tablet Batch (g) %

1 Amoxicillin trihydrate 1148 114,8

2 Avicel PH 102 500 50

3 Crospovidone 54 5,4 3

4 Magnesium stearate 50 5

5 Aspartame 18 1,8

6 Strawberry flavor 18 1,8

Total 1788 178,8

- Process:

Step Description

1. Pulverize raw material.

2. Pass Amoxicillin trihydrate through 30 mesh (600 μm)

Avicel PH 101, Crospovidone, Aspartame, Strawberry through 40 mesh (430 μm)
.[1,2]

3. The sifted and milled Amoxicillin trihydrate fractions were mixed in a blender for 5
minutes [2]

4. Sifted Avicel PH 101, Crospovidone, Aspartame, Strawberry were added into

blender, mix for 10 minutes [2]

5. Pass Magnesium stearate through 60 mesh (250 μm), then added to the blender,
mix for 5 minutes [1,2]

6. Compress final mixing granule.

Result:

Batch No: Trial 02 (100 tablets)

No Parameter Specification Result

1. Disintegration Within 3 min in water at ± 25oC Conduct the test with 6 tablets on
Time 2 test tube racks installed in
parallel or repeat the test on 1 test
tube rack. Place one tablet in
each test tube. Suspend the test
tube holder in a beaker containing
the specified medium maintained
at (37 ± 2) °C and operate the
instrument for the specified time.
Remove the test tube holder from
the liquid and observe the test
preparation. The test sample
meets the requirements if all 6
tablets disintegrate.

2. Uniformity of Mean ± 5% Weigh individually 20 units taken

mass at random or, for single-dose
preparations presented in
individual containers, the contents
of 20 units, and determine the
average mass. Not more than 2 of
the individual masses deviate
from the average mass by more
than the percentage deviation
shown in Table 2.9.5.-1 and none
deviates by more than twice that
percentage.

3. Dissolution Not less than 80% (Q) of the amount of
Amoxicillin of the amount stated above
must be dissolved in 60 min.
Take an amount of solution, filter,
discard the first 10 ml of filtrate,
and dilute if necessary. Measure
the absorbance at the maximum
wavelength of about 272 nm
(Appendix 4.1), in a 1 cm thick
measuring cup, the blank sample
is water. Compare with standard
amoxicillin trihydrate solution in
water of equivalent concentration.
 Calculate the content of
amoxicillin.

4 Assay 90.0 % to 120.0 % of the amount stated Solution A: Dissolve 13.6 g

on the label. potassium dihydrophosphate (TT)
in 2000 ml water, adjust to pH 5.0
± 0.1 with 45% potassium
hydroxide solution.
Mobile phase: Solution A –
acetonitrile (96:4). Adjust the
acetonitrile ratio to achieve the
required chromatographic
conditions (if necessary).
Standard solution: Mix standard
amoxicillin trihydrate in solution A
to have an accurate amoxicillin
concentration of about 1.2 mg/ml
(use within 6 hours only).
Test solution: Weigh 20 tablets,
calculate average weight, grind
into fine powder. Accurately weigh
a quantity of pellets corresponding
to about 0.2 g of amoxicillin into a
200 ml volumetric flask, add
solution A, shake ultrasonic to
dissolve, add to volume with the
same solvent, mix well and filter
through a membrane. filter with a
pore size of no more than 1 pm
(only used within 6 hours).
Chromatographic conditions
Column size (25 cm X 4 mm) is
packed with stationary phase c(3
µm to 10 µm).
Ultraviolet spectroscopy detector
set at 230 nm wavelength.
Flow rate: 1.5 ml/min.
Injection volume: 10 µl.
How to proceed:
Check the suitability of the
system: Inject the standard
solution, calculated based on the
main peak obtained in the
chromatogram: the capacity factor
must be between 1.1 and 2.8; The
theoretical number of plates of the
column is not less than 1700; The
symmetry factor is not greater
than 2.5 and the relative standard
deviation of the peak areas from 6
 replicate injections of the standard
sample is not greater than 2.0%.
Inject test solution and standard
solution separately.
Calculate the amoxicillin content,
C16H19N305S, in the tablet from
the peak areas in the
chromatograms of the standard
and test solutions and the
C16H19N305S content in the
standard amoxicillin trihydrate.

5. Water Not more than 13.0 % VP5 <80>

Use about 0.15 g of pellets.

6. Friability 0,5 - 1% Take a sample of 10 whole

tablets. The tablets should be
carefully dedusted prior to testing.
Accurately weigh the tablet
sample, and place the tablets in
the drum. Rotate the drum 100
times, and remove the tablets.
Remove any loose dust from the
tablets as before, and accurately
weigh.

7. Uniformity of Add 2 tablets to 100 ml of water, stir until VP <80>

dispersion completely dispersed. Dispersion is
satisfactory when the dispersion solution
flows completely through the sieve hole
with sieve size 710 μm.

Trial 03: Investigation of disintegrants

Batch size: 100 tablets

Batch size: 100 tablets

No Name of raw material mg/tablet Batch (g) %

1 Amoxicillin trihydrate 1148 114,8

2 Avicel PH 102 500 50

3 Crospovidone 72 7,2 4

4 Magnesium stearate 50 5

5 Aspartame 18 1,8

6 Strawberry flavor 18 1,8

Total 1806 180,6

- Process:

Step Description

1. Pulverize raw material.

2. Pass Amoxicillin trihydrate through 30 mesh (600 μm)

Avicel PH 101, Crospovidone, Aspartame, Strawberry through 40 mesh (430 μm)
.[1,2]

3. The sifted and milled Amoxicillin trihydrate fractions were mixed in a blender for 5
minutes [2]

4. Sifted Avicel PH 101, Crospovidone, Aspartame, Strawberry were added into

blender, mix for 10 minutes [2]

5. Pass Magnesium stearate through 60 mesh (250 μm), then added to the blender,
mix for 5 minutes [1,2]

6. Compress final mixing granule.

Result:

Batch No: Trial 03 (100 tablets)

No Parameter Specification Result

1. Disintegration Within 3 min in water at ± 25oC Conduct the test with 6 tablets on
Time 2 test tube racks installed in
parallel or repeat the test on 1 test
tube rack. Place one tablet in
 each test tube. Suspend the test
tube holder in a beaker containing
the specified medium maintained
at (37 ± 2) °C and operate the
instrument for the specified time.
Remove the test tube holder from
the liquid and observe the test
preparation. The test sample
meets the requirements if all 6
tablets disintegrate.

2. Uniformity of Mean ± 5% Weigh individually 20 units taken

mass at random or, for single-dose
preparations presented in
individual containers, the contents
of 20 units, and determine the
average mass. Not more than 2 of
the individual masses deviate
from the average mass by more
than the percentage deviation
shown in Table 2.9.5.-1 and none
deviates by more than twice that
percentage.

3. Dissolution Not less than 80% (Q) of the amount of
Amoxicillin of the amount stated above
must be dissolved in 60 min.
Take an amount of solution, filter,
discard the first 10 ml of filtrate,
and dilute if necessary. Measure
the absorbance at the maximum
wavelength of about 272 nm
(Appendix 4.1), in a 1 cm thick
measuring cup, the blank sample
is water. Compare with standard
amoxicillin trihydrate solution in
water of equivalent concentration.
Calculate the content of
amoxicillin.

4 Assay 90.0 % to 120.0 % of the amount stated Solution A: Dissolve 13.6 g

on the label. potassium dihydrophosphate (TT)
in 2000 ml water, adjust to pH 5.0
± 0.1 with 45% potassium
hydroxide solution.
Mobile phase: Solution A –
acetonitrile (96:4). Adjust the
acetonitrile ratio to achieve the
required chromatographic
conditions (if necessary).
Standard solution: Mix standard
amoxicillin trihydrate in solution A
to have an accurate amoxicillin
concentration of about 1.2 mg/ml
(use within 6 hours only).
Test solution: Weigh 20 tablets,
calculate average weight, grind
into fine powder. Accurately weigh
a quantity of pellets corresponding
to about 0.2 g of amoxicillin into a
200 ml volumetric flask, add
solution A, shake ultrasonic to
dissolve, add to volume with the
same solvent, mix well and filter
through a membrane. filter with a
pore size of no more than 1 pm
(only used within 6 hours).
Chromatographic conditions
Column size (25 cm X 4 mm) is
packed with stationary phase c(3
µm to 10 µm).
Ultraviolet spectroscopy detector
set at 230 nm wavelength.
Flow rate: 1.5 ml/min.
Injection volume: 10 µl.
How to proceed:
Check the suitability of the
system: Inject the standard
solution, calculated based on the
main peak obtained in the
chromatogram: the capacity factor
must be between 1.1 and 2.8; The
theoretical number of plates of the
column is not less than 1700; The
symmetry factor is not greater
than 2.5 and the relative standard
deviation of the peak areas from 6
replicate injections of the standard
sample is not greater than 2.0%.
Inject test solution and standard
solution separately.
Calculate the amoxicillin content,
C16H19N305S, in the tablet from
the peak areas in the
chromatograms of the standard
and test solutions and the
C16H19N305S content in the
standard amoxicillin trihydrate.
 5. Water Not more than 13.0 % VP5 <10.3>
Use about 0.15 g of pellets.

6. Friability 0,5 - 1% Take a sample of 10 whole

tablets. The tablets should be
carefully dedusted prior to testing.
Accurately weigh the tablet
sample, and place the tablets in
the drum. Rotate the drum 100
times, and remove the tablets.
Remove any loose dust from the
tablets as before, and accurately
weigh.

7. Uniformity of Add 2 tablets to 100 ml of water, stir until VP <80>

dispersion completely dispersed. Dispersion is
satisfactory when the dispersion solution
flows completely through the sieve hole
with sieve size 710 μm.

Continue to investigate disintegrants, then choose the final formula that the result meet all
parameter of finished product specification. After that, the product was stored in acelerated
condition to evaluate the stability of the finished product.

Result stability of lab scale batch

Product name: Amoxi almus 1g Dosage form: Dispersible tablets

Batch number: Trial … Presentation: …

Testing Appea Assay (% on the Dissolution Impurity
freque- -rance label)
ncy
(month
)

NA Amoxicillin Conclusi Tablet Tablet Tablet Tablet Tablet Tablet Aver Con Tạp Tạp Tạp đơn Tổng Conclusion
-on 1 2 3 4 5 6 -age clusi A C khác tạp
on cao
nhất