TUGAS MAKALAH MATA KULIAH STERIL

Mencari Formula Sediaan Salep Mata dan Suspensi

Harzelin Sugeng K
201510410311106
Farmasi D

PROGRAM STUDI FARMASI

FAKULTAS ILMU KESEHATAN
UNIVERSITAS MUHAMMADIYAH MALANG
2019

i
 SEDIAAN TETES MATA

Sterile Pharmaceutical Formulations 267

Neomycin and Prednisolone Acetate Ophthalmic Suspension

MANUFACTURING DIRECTIONS
Caution: Hazardous handling of prednisolone and neomycin; observe protection and precaution.
Protect the preparation from light after adding neomycin and Polymyxin B.

PART I
1. Add Item 1 into a 2-L grinding jar filled to about half with glass beads; add 300 mL of Item 4
to it and then 250 mL of Item 3.
2. Seal the jar with a Teflon stopper and mix until the steroid has been wetted; remove the
stopper and wrap the mount of jar with a double layer of aluminum foil and a double layer of
parchment paper, and secure it with steel wires. 268 Handbook of Pharmaceutical
Manufacturing Formulations: Sterile Products
3. Sterilize the jar by autoclaving for at least 2 h and 30 min at 121°C; remove the jar from the
autoclave and allow it to cool to room temperature.
4. Transfer 800 mL of Item 4 into a 1-L flask; wrap the mouth of the flask with a double layer of
aluminum foil and a double layer of parchment paper, and secure the two rubber bands.

2
 5. Sterilize Item 4 by autoclaving for 30 min minimum at 121°C; remove the flask from the
autoclave and allow it to cool to room temperature.
6. Wrap a Teflon stopper that will fit the mouth of the grinding jar with two layers of aluminum
foil; sterilize the Teflon stopper by autoclaving for at least 30 min at 121°C.
7. Aseptically (under a laminar flow hood, with appropriate gowning) add as much of the 800
mL of sterile Item 4 as it takes to fill the grinding jar to the neck. Seal the grinding jar with
the sterilized Teflon stopper, cover the Teflon stopper with double layers of aluminum and
double layers of parchment paper, and secure the parchment paper and aluminum foil with
two steel wires.
8. Place the grinding jar on the mill and grind until the particle size is approved by QC.

PART II
1. Measure out ca. 20 L of Item 5 into a container suitable for heating. Begin mixing with a
suitable mixer. Heat the Item 4 to 85∞C to 90°C.
2. Measure out 15 L of heated Item 5 into a 20-L container; begin mixing with a propeller
mixer.
3. Add Item 6 slowly to the vortex. Avoid formation of excessive foam. Mix for at least 90 min
until it is completely dissolved (mixing time not less than 90 min).
4. Add Item 7, 10% solution, and mix well; cool to room temperature.

PART III
1. Measure out ca. 37 L of Item 8 into a mixing tank suitably calibrated for a final QS of 60 L;
begin mixing.
2. Add Items 9, 10, 11, and 12, in order, allowing each to mix thoroughly or dissolve completely
before adding the next.
3. Add Part II to the mixing tank containing Part III while mixing Part III.
4. Use 3 to 4 L of Item 8 to rinse the Part II container; add the rinsings to the mixing tank; mix
thoroughly.

PART IV
1. Weigh out Item 14 and carefully transfer it to a suitable flask.
2. Add 200 mL of Item 13 and mix until Item 14 is dissolved.
3. Add Part IV to combined Parts II and III, and mix thoroughly.
4. Rinse the Part IV flask with ca. 200 mL of Item 15 and add the rinsings to the mixing tank.
5. Allow any foam to dissipate and QS the combined solution of Parts II, III, and IV (Product
Base) to 60 L with Item 15; mix thoroughly for at least 15 min.
6. Take a 60-mL sample of combined Parts II, III, and IV product base for bulk assay.

STERILE FILTRATION
Note: Sterile filter 40-L of combined Parts II, III, and IV Base, using an approved 0.2-mm filter.
1. Sterilize for 1 h (range 45 to 60 min) at 121°C (–0, +5∞C) in an autoclave at 15 psi in a 100-L
stainless steel pressure vessel. Transfer to solution preparation area.
2. Mix the product for at least 10 min before filtration.
3. Connect the sterilized filter and sterile filter with the aid of N2 pressure (15 to 30 lb) into the
sterilized 100-L stainless steel pressure vessel. Note: Before sterile filtration to the 100-L
pressure vessel, perform the bubble point test at NLT 40 psi and on a 0.22-mm in-line gas
filter at 18 psi.
4. After completion of product filtration, flush the sterilizing filter with at least 10 L of water
purified (distilled).
5. After filtration, decontaminate the outer surface of the bulk holding the pressure vessel and
then transfer to filling cubicle; discard NLT 10 Lthrough the sterilized filter prior to
connecting on the sterile filling lead line.
6. QA sample for bulk assay. Discard any remaining base portion, after keeping 40 L of the
combined Parts II, III, and IV.

3
STERILIZATION
Sterilize filling unit, 20-L surge bottle, P2 sintered glass filter, and uniforms at 121°C (–0°, +2°C) and
15 psi for 1 h. Sterile Pharmaceutical Formulations 269

PART V
1. Measure out and transfer Item 17 into a suitable glass bottle. Seal the mouth of the bottle with
two layers of aluminum foil and two layers of parchment paper; secure the aluminum foil and
parchment paper with two rubber bands.
2. Sterilize Item 17 by autoclaving for at least 60 min at 121°C. Remove the bottle from the
autoclave and allow it to cool to room temperature.

MIXING PROCEDURE
Note: Perform all mixing of steroid under aseptic conditions. Product is light sensitive.
1. Grind the steroid (Part I) for at least 6 h before mixing.
2. Aseptically receive 40.0 L of sterile filtered product base (combined Parts II, III, and IV) into
a sterilized glass bottle calibrated at 40.0 and 45.0 L.
3. Place the glass bottle containing the product base (combined Parts II, III, and IV) on a
magnetic mixing table.
4. Place the bottle and magnetic mixer in front of a laminar air flow hood.
5. Aseptically add a sterilized magnetic stirring bar to the glass bottle containing the product
base. Adjust the mixing speed such that a 10.5- in. deep vortex is formed.
6. Aseptically pour the ground prednisolone acetate, Part I, from the grinding jar through a
sterilized polyethylene Buchner funnel into the bottle containing the product base. Rinse the
grinding jar and the funnel with the sterilized water purified (distilled) (Part V).
7. Add the rinsings to the bottle containing Parts II, III, and IV. The volume of the suspension
in the bottle should now be 45 L. Remove the Buchner funnel and insert a sterilized closing
stopper into the mouth of the bottle containing combined Parts I, II, III, IV, and V.
8. Allow the product to mix with a 0.5-in.-deep vortex for at least 2 h. Continue mixing at this
setting.

HOMOGENIZATION PROCEDURE
Homogenize the product suspension in a sterilized homogenizer. Filter the suspension through filter
into an empty 45-L sterilized glass bottle located in the filling room. Aseptically add a sterilized
magnetic stirring bar to the empty 45-L sterilized glass bottle located in the filling room. Place the
empty 45-L sterilized glass bottle onto a magnetic mixing table. Adjust the homogenizer controls
while cycling the suspension from the bottle through the sterilized homogenizer back to the bottle.

STERILE FILLING
1. Transfer the radiation-sterilized bottles, plugs, and caps to the filling cubicle after swabbing
their outer polyethylene packing with filtered methylated spirit and keep under the laminar
flow hood.
2. Transfer the sterilized assembly line to the filling room; wear surgical gloves and uniforms.
Aseptically connect the sterilized filling tubing and N 2 line from the 100-L pressure vessel to
the surge bottle.
3. Aseptically fill 5.4 mL of sterile solution through P2 sintered glass into the sterilized con-
tainer by using the automatic filling, plugging, and sealing machine and apply sterile closure
components (plugs and caps). Note: While filtering, do not exceed to N2 pressure of 5 to 10
lb.
4. Perform the bubble point test on a 0.22-mm in line gas filter before and after filtration at 18
psi.

4
Hal. 128
Handbook of Pharmaceutical Manufacturing Formulations: Sterile Products
Chloramphenicol and Phenylmercuric Nitrate Ophthalmic Drops

MANUFACTURING DIRECTIONS
Note:
Weigh out the chloramphenicol in the antibiotic weigh room. Be careful to prevent any cross
contamination of the antibiotic during weighing and handling. The temperature of Part I is critical and
must be precisely controlled or precipitation may result. Mixing must be continuous while adding Part
II to Part I or precipitation may result.

PART I
1. Add Items 1 and 2 to a suitable water-jacketed heating kettle of at least 45-L capacity. Begin
mixing with a suitable mixer.
2. Heat to 85 ∞ C to 90°C while mixing. Do not allow the temperature to rise above 90°C. Mix
until all of Item 2 has melted.
3. When all of the Item 2 has melted, turn off the heat source and allow the mixture to cool to
53°C to 55°C by circulating cold water through the kettle jacket.
4. When the temperature of Part I reaches 53°C to 55°C, add Item 3. Mix thoroughly for at least
15 min.
5. Maintain the temperature of Part I at 53°C to 55°C, and immediately add Part II at 50°C to
52°C according to the instructions that follow.
PART II
1. Measure out ca. 25 L of Item 4 into a suitable water jacketed heating kettle. Begin mixing.
2. Add Items 5 and blended Item 6, in order, allowing the first to dissolve completely before
adding the next. Rinse out the blender cup with Item 9 and add the rinsings to the kettle.
3. Heat Part II to 50°C to 52°C.
4. With Part I at 53°C to 55°C and Part II at 50°C to 52°C, add Part II to Part I, while mixing
Parts I and II.
5. Use 4 to 5 L of Item 9 to rinse the Part II kettle, pump, and hoses.
6. Add the rinsings to combined Parts I and II. Continue mixing and allow the batch to cool to
30°C or below.
7. When the temperature is at 30°C or below, transfer the batch into a suitable mixing tank for a
final QS of 45 L.
8. Use 2 to 3 L of Item 9 to rinse out the kettle, pump, and hoses. Add the rinsings to the cali-
brated mixing tank. Mix well for at least 15 min.
9. Check pH (range 5.4 to 5.8). If necessary, adjust the pH to 5.4 to 5.8 with Item 7 or 8.
10. Allow any foam to dissipate and QS the batch to 45 L with Item 9. Mix thoroughly for at least
15 min.

5
STERILE FILTRATION
1. Sterilize for 1 h (range 45 to 60 min) at 121°C(-0, +5°C) in an autoclave at 15 psi, and then
filter to a 100-L stainless steel pressure vessel. Transfer to solution preparation area.
2. Mix the product for at least 10 min before filtration.
3. Connect the sterilized filter and sterile-filter with the aid of N2 pressure (15 to 30 lb). Discard
initial 10 L of filtrate, attach sterilized hose to sterilized filter holder, and connect to the
sterilized 100-L stainless steel pressure vessel asep-tically.
Note:
Before sterile filtration to 100-L pressure vessel, perform the bubble point test at NLT 40 psi and on
0.22-mm in-line gas filter at 18 psi.

4. After completion of product filtration, discon- nect filter from pressure vessel and flush the
sterilizing filter with at least 10 L of water purified (distilled) for the bubble point test (after
filtration).
5. After filtration, decontaminate the outer surface of bulk holding pressure vessel and then
transfer to filling cubicle. Sample.

STERILIZATION
1. Filling unit, 20-L surge bottle, manifold of filling unit, and uniforms.
2. Sterilize at 121°C (-0°, +2°C) pressure 15 psi for 1 h.

STERILE FILLING
1. Aseptically connect the sterilized filling tubingand N2 line from 100-L pressure vessel to
surge bottle.
2. Aseptically fill sterile solution into sterilized container.
3. Perform the bubble point test on a 0.22-mm in-line gas filter, before and after filtration at
18psi. Sample

6
 SEDIAN SALEP MATA

Salep mata Tetrasiklin Hidroklorida 1 % dalam 10 g (USP ED 26)

R/ Tetrasiklin Hidroklorida 100 mg (bahan aktif)

Setil alkohol 0,25 g (emulsifying agent)
Parafin cair 4 g (solvent)
Vaselin Kuning ad 10 g (ointment base)

Cara Pembuatan Salep Mata

1. Timbang semua bahan yang diperlukan

2. Alat – alat gelas termasuk mortir dan stemper di sterilisasi di autoklaf 30 menit
parafin cair,vaselin kuning,setil alkohol di oven selama 15’ dan Tetrasiklin Hidroklorida di
sinar UV 15’
3. Mortir & stemper yand dari autoklaf di dinginkan dahulu hingga (hangat)
4. Masukan setil alkohol+adeps lanae+parafin cair dan vaselin flavum secara berurutan masuk
dalam mortir
5. Aduk cepat ad homogen,terakhir masukan Tetrasiklin Hidroklorida aduk ad homogen
6. Salep dimasukan ke dalam pot
7. Evaluasi

Menurut (Materia Medika Jilid 1 , 1978) hal 66

Formula Standar
Tiap gram mengandung :
R/ Chloramfenicolum 10mg
Oculentum Simplek ad 1g

maka Tiap 10 gram salep mengandung :

R/ Chloramfenikol 100mg (Bahan aktif)
Setil alkohol 2,5% (emulsifying agent)
Adeps lanae 6% (basis salep)
Parafin Cair 40% (basis salep)
Vaselin Kuning ad 10g (basis salep)

Cara Pembuatan Salep Mata

1. Timbang semua bahan yang diperlukan

2. Alat – alat gelas termasuk mortir dan stemper di sterilisasi di autoklaf 30 menit Adeps
lanae,parafin cair,basis,setil alkohol di oven selama 15’ dan kloramfenikol di sinar UV 15’
3. Mortir & stemper yand dari autoklaf di dinginkan dahulu hingga (hangat)
4. Masukan setil alkohol+adeps lanae+parafin cair dan vaselin flavum secara berurutan
5. masukkan dalam mortir
6. Aduk cepat ad homogen,terakhir masukan kloramfenikol aduk ad homogen
7. Salep dimasukan ke dalam pot
8. Evaluasi

7
8