Steril 2

Laboratorium Farmasetika
Fakultas Farmasi
Universitas Hasanuddin
DOKUMEN RANCANGAN PENGEMBANGAN PRODUK

PARACET® Infus
(TABLET ASPIRIN SALUT FILM)
PT. FARSET LABS.
Disusun Oleh:
1. Formulation Development Scientist #1 : Achmad Himawan/N111 07 038

2. Formulation Development Scientist #2 : Rangga Meidianto Asri/N111 07 039
3. Process Development Scientist : Hermanto Utomo/N111 07 037
4. Analytical Method Development Scientist : Stefanus Yudha Pratomo Sumito/N111 07 036
5. Packaging Development Scientist : Andika Takdir Mulia/N111 07 040
Supervisors:
Sandra Aulia Mardikasari
Andi Arjuna
Nomor Dokumen :
Tanggal Penuyusunan :
Taggal Pengesahahan :
MAKASSAR, 2020
Paracet® Infus, 10 mg/ml, 19DRP.IN.A1-XXXXX
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EXECUTIVE SUMMARY
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TINJAUAN TERHADAP PRODUK REFERENSI/PRODUK PEMBANDING
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Bagian 1 Identitas Produk
No. Item Uraian
1 Nama Produsen
2 Nama Produk
3 Kandungan Bahan Aktif
4 Kekuatan Sediaan
5 Nomor Registrasi
6 Indikasi Sediaan
7 Golongan Obat*
*Menurut Undang-Undang
Bagian 2 Quality Target Product Profile (QTPP)
No. Elemen QTPP Target Justifikasi
1 Bentuk Sediaan
2 Desain sediaan
3 Rute Pemberian
4 Kekuatan Sediaan
5 Farmakokinetika
6 Stabilitas
7 Wadah Primer
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Bagian 3 Quality Attribute (Drug Product)
No. Quality Attribute Target Justifikasi
Pemerian
Bau
Warna
Atribut
1
Fisik
Rasa
Bobot
Dimensi
2 Identifikasi
3 Assay
Keseragaman
4
Kandungan
5 Impurities
6 pH
7 Viskositas
8 Volume Terpindahkan
9 Sterilitas
10 Endotoksin
11 Partikel Sub-visibel
12 Osmolaritas
13 Kerapatan
14 Integritas Wadah
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Bagian 4 Rancangan Formula
Tiap 10 ml sediaan mengandung:
Ketorolac 0,5% (ZA)fix

Natrium Klorida 0,9% (Isotonicity)
Benzetonium klorida 0.01% (Preservative)
Buffer fosfat q.s
Purified water ad 100% (Pembawa)
* Konsentrasi bahan aktif oral ditulis dalam mg, konsentrasi bahan tambahan/bahan aktif topikal dalam %
**Bahan pengisi/pembawa/basis ditulis paling akhir, add 100%
Bagian 5 Dasar Formulasi
A. Dasar Pembuatan Sediaan (5)
The application of the therapeutic agents directly to the site of action ensures that the therapeutic
agent is available at higher concentrations than may be achieved following oral administration.
Administration of the therapeutic agent locally ensures that the incidence of side-effects is
minimised. Following training, the administration of the dosage form locally to the eye may be
easily performed by the patient. Eye drop formulations are generally preferred to ocular ointments
by patients due to the ease of administration and non-blurring of vision associated with eye drops
(Fasttrack : 147 & 161).
These are by far the most common dosage forms for delivering drugs to the eye. By defmition,
ingredients are completely soluble such that dose uniformity is not an issue and there is little
physical interference with vision. The principal disadvantage of solutions is their relatively
briefcontact time with the drug and the absorbing tissues of the external eye. Con tact time may
be increased by the inclusion of a viscosity-imparting agent; however, their use is limited to
relatively low viscosities so that the eyedrop can be dispensed from the container or eyedropper
and to minimize excessive blurring ofvision. A viscous solution can produce a residue on the
eyelashes and around the eye when any excess spills out of the eye and dries. The residue can usu
ally be easily removed by careful wiping with a moist towel to the closed eye (Remington: 856)
Although a few commercial ophthalmic solutions and suspensions are packaged in small glass
bottles with separate glass or plastic droppers, most are packaged in soft plastic containers with a
fixed built-in dropper. This type of packaging is preferred both to facilitate administration and to
protect the product from external contamination. Ophthalmic solutions and suspensions are
commonly packaged in containersholding 2, 2.5, 5, 10, 15, and 30 mL of product (Ansel 10: 617).
Various ophthalmic delivery systems have been investigated to increase the corneal permeability
and prolong the contact time with the ocular surface. However, conventional eye drops prepared
and administered as aqueous solutions remain the most commonly used dosage form in ocular
disease management (Pharmaceutical Manufacturing Handbook Production and Processes: 737).
Ocular topical drug delivery is particularly challenging because of the inherent difficulties
associated with absorption of topically applied drugs into the eye. Ophthalmic dosage forms are
administered via the topical route to treat both surface and intraocular conditions. Consideration
of the anatomical and physiological features of the eye, as well as the physicochemical properties
of the drug, are all important when developing a topical ophthalmic delivery system
(Pharmaceutical preformulation and formulation: 460)
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B. Dasar Pemilihan Bahan Aktif (3) dan Kekuatan Sediaan (3)

Ketorolac is an NSAID promoted for systemic use mainly as an analgesic, not as an
antiinflammatory drug (though it has typical NSAID properties). The drug does appear to have
significant analgesic efficacy and has been used successfully to replace morphine in some
situations involving mild to moderate postsurgical pain. It is most often given intramuscularly or
intravenously, but an oral dose formulation is available. When used with an opioid, it may decrease
the opioid requirement by 25–50%. An ophthalmic preparation is available for anti-inflammatory
applications. Toxicities are similar to those of other NSAIDs, although renal toxicity may be more
common with chronic use. (Katzung: 822)
Ketorolac tromethamine shares the toxic potentials of nonsteroidal anti-inflammatory agents

(NSAIAs); when NSAIAs are administered short-term (AHFS 2004: 11237).
Ketorolac tromethmaine is a nonsteroidal anti-inflammatory drug. It is used as Antipyretic, anti-
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inflammatory and analgesic. It is indicated Ketorolac tromethamine ophthalmic solution is

indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac
tromethamine ophthalmic solution is also indicated for the treatment of postoperative
inflammation in patients who have undergone cataract extraction. Sterility is an absolute
requirement of all ophthalmic formulation. Contaminated ophthalmic formulation may result in
eye infection that could ultimately cause blindness, especially if Pseudomonas aeruginosa
microbes are involved (FDA).
Ketorolac trometamol is used as 0.5% eye drops to relieve ocular itching associated with seasonal
allergic conjunctivitis. Ketorolac trometamol eye drops 0.5% have also been used for the topical
treatment of cystoid macular oedema and for the prevention and reduction of inflammation
associated with ocular surgery (Martindle: 75).
Based on FDA 10 ml size bottle filled with 5 ml of ketorolac tromethamine ophthalmic solution,
0.5% (5 mg/ml) (FDA).
Children ≥3 years of age undergoing ocular incisional refractive surgery: 1 drop (250 mcg) of a 0.5%
preservative-free solution 4 times daily in the eye(s) that underwent surgery as needed for up to 3
days after surgeryChildren ≥3 years of age undergoing corneal refractive surgery: 1 drop (200 mcg)
of a 0.4% solution 4 times daily in the eye(s) that underwent surgery as needed for up to 4 days
after surgery. Children ≥3 years of age: 1 drop (250 mg) of a 0.5% solution in the affected eye(s) 4
times daily (AHFS 2012).
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C. Dasar Pemilihan Bahan Tambahan (4)

Natrium Klorida
Sodium chloride is widely used in a variety of parenteral and nonparenteral pharmaceutical

formulations, where the primary use is to produce isotonic solutions. The addition of sodium
chloride to aqueous spray-coating solutions containing hydroxypropyl cellulose or hypromellose
suppresses the agglomeration of crystalline cellulose particles. It can be used to control micelle
size, and to adjust the viscosity of polymer dispersions by altering the ionic character of a
formulation. Concentration for isotonity <0.9 (Excipients: 637).
A variety of agents are used in sterile products to adjust tonicity. Most common are simple
electrolytes such as sodium chloride or other sodium salts and non-electrolytes such as glycerin
and lactose. Tonicity adjusters are usually the last ingredient added to the formulation after other
ingredients in the formulation are established and the osmolality of the formulation measured. If
the formulation is still hypotonic (i.e.,<280 mOsm/kg as measured by a commonly used osmometer
instrument), tonicity adjusting agents are added until the formulation is isotonic (Encyclopedia:
1275).
It is recommended that parenteral formulations designed for IV administration should not be
hypotonic. Therefore, hypotonic solutions should be rendered isotonic by the addition of
compounds that will increase the osmotic pressure of the solution. Typically sodium chloride or
dextrose is used for this purpose. There are two methods by which the mass of these compounds
required to render the solution isotonic may be calculated: (1) consideration of the gram-
molecular concentration; and (2) consideration of the freezing-point depression of the solution.
These are individually addressed below (Fasstrack: 121).
A solution is isotonic with a living cell if there is no net gain or loss ofwater by the cell, or other
change in the cell, when it is in contact with that solution. Physiological solutions with an osmotic
pressure lower than that of body fluids, or of 0.9% sodium chloride solution, are referred to
commonly as being hypotonic. Physiological solutions having a greater osmotic pressure are
termed hyperwnic (Remington: 273).
Benzetonium klorida
Structural formula of benzethonium chloride. It is commonly used in ophthalmic formulations
within the concentration range of 0.01–0.02% w/v (although it has been reported to exhibit lower
antimicrobial activity than benzalkonium chloride) (Fasstrack: 144).
To maintain sterility during use, antimicrobial preservatives generally are included in ophthalmic
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formulations; an exception is for preparations to be used during surgery or in the treatment of

traumatized eyes because some preservatives irritate the eye. These preservative-free
preparations are packaged in single-use containers. During preformulation studies, antimicrobial
preservatives must demonstrate stability, chemical and physical compatibility with other
formulation and packaging components, and effectiveness at the concentration employed. Among
the antimicrobial
preservatives used in ophthalmic solutions and suspensions and their effective concentrations are
benzethonium chloride, 0.01%; In concentrations tolerated by the eye, all of the aforementioned
preservative agents are ineffective against some strains of Pseudomonas aeruginosa, which can
invade an abraded cornea and cause ulceration and even blindness (Ansel 10: 609).
Benzethonium chloride is a quaternary ammonium compound used in pharmaceutical
formulations as an antimicrobial preservative. Typically, it is used for this purpose in injections,
ophthalmic and otic preparations at concentrations 0.01–0.02% w/v (Exicipients: 59).
Due to the safety and regulatory concerns raised by preservatives used in ophthalmic products,
there have been efforts to develop new eye-drop packaging systems which can remove the
preservative from the formulation during administration. BKC is the most common preservative
used in commercial eye-drops, and yet there are reports of side-effects such as allergic reactions,
irritation, decreased lacrimation and damage to the corneal endothelium caused by its multiple
use in eye products (Fraunfelder and Meyer 1989). Also, BKC can accumulate in soft contact lenses
and is therefore not recommended for these patients. A French pharmaceutical research company,
Transphyto, have patented a multidose preserved ophthalmic product with an adsorbant
membrane in the neck of the bottle to remove the preservative during administration. It also
contains a 0.2 bacteriological membrane to prevent the ingress of bacteria into the bottle during
use (Pharmaceutical preformulation and formulation: 470-471).
Disodium fosfat (Buffer fosfat)

Penggunaan buffer dalam formulasi bertujuan untuk menjaga pH sediaan sesuai dengan
persyaratannya, karena perubahan pH dapat menyebabkan perubahan laju reaksi penguraian yang
dapat terjadi selama penyimpanan. Oleh karena itu, digunakan dapar fosfat karena merupakan
sistem dapar utama (Lachman 3 : 1302).
The pH and the control of the pH of ocular formulations are important determinants of the stability
of the therapeutic agent, the ocular acceptability of the formulation and the absorption of the drug
across the cornea. Ideally the pH of the formulation should be that which maximises the chemical
stability (and, if required, absorption) of the formulation. This issue is particularly important due to
the effect of pH on the stability. As highlighted in the previous section, the pH and the buffer
capacity directly affect the subsequent discomfort of the formulation. Ideally the pH of the ocular
solution should be controlled at 7.4 as this is the pH of tear fluid. However, the choice of pH of the
formulation is also dictated by the stability of the therapeutic agent at that pH (which in turn
serves to define the shelf-life of the formulation) and whether (or not) absorption of the active
agent across the cornea is required. Phosphate buffers may be used to control the pH of eye drops
(at physiological pH). Finally it should be remembered that control of the pH is often used to
prevent precipitation of the therapeutic agent in the formulation (Fasstrack: 141).
Dibasic sodium phosphate is used in a wide variety of pharmaceutical formulations as a buffering
agent and as a sequestering agent (Exicipients: 656).
The pH of an ophthalmic preparation may be adjusted and buffered for one or more of the
following purposes The pH of normal tears is considered to be about 7.4, but it varies; for example,
it is more acidic in contact lens wearers (9). Tears have some buffer capacity. However, this is not
pharmaceutically possible, because at pH 7.4 many drugs are insoluble in water (Ansel 10: 612).
Purified water (pembawa)

Pada sediaan steril digunakan pembawa air yang merupakan pembawa untuk semua cairan tubuh
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(Lachman 3 : 1294).
The vehicle that is predominantly used for the formulation of aqueous ocular dosage forms is
Purified Water USP. Water for injections is not a specific formulation requirement. Occasionally oil
is used if the therapeutic agent is profoundly unstable within an aqueous vehicle. The choice of oils
for ocular use is similar to that for parenteral use (Fasstrack: 141).
Naturally occurring water exerts its solvent effect on most substances it contacts and, thus, is
impure, containing varying amounts of dissolved inorganic salts, usually sodium, potassium,
calcium, magnesium, and iron; chlorides; sulfates; and bicarbonates, along with dissolved and
undissolved organic matter and microorganisms. Water found in most cities and towns where
water is purified for drinking usually contains less than 0.1% of total solids, determined by
evaporating a 100-mL sample to dryness and weighing the residue (which weighs <100 mg) (Ansel:
403).
The US Pharmacopeia (USP) contains specifications for several grades of water used in the
preparation of medicinal products. The two grades most often used in the pharmaceutical plants
are USP Purified Water and Water For Injection (WFI). As the name implies, WFI is used for the
preparation of injectable drugs, whereas USP Purified Water can be used in the manufacturing of
tablets, capsules, creams, lotions, etc. These types of water are called ‘‘compendial’’ because their
quality is specified in an official nationally recognized standard such as USP. In addition, many
companies use various non-compendial water systems designed for specific needs. While designing
the facility, it is important to decide on the proper grades of water to use in various applications.
Compendial waters are typically very expensive, not only because of required treatment steps, but
also because of extensive validation and testing requirements (Encyclopedia: 4039).
HPMC (Viscosity)
Hydroxypropylmethylcellulose (HPMC) is a partially methylated and O-(2-hydroxypropylated)
cellulose derivative In aqueous ocular formulations HPMC is used in the concentration of 0.45–
1.0% w/w (Fasstrack: 142-143).
In the preparation of ophthalmic solutions, a suitable grade of methylcellulose or other thickening
agent is frequently added to increase the viscosity and thereby aid in maintaining the drug in
contact with the tissues to enhance therapeutic effectiveness. Generally, methylcellulose of 4,000
cP is used in concentrations of 0.25% and the 25-cP type at 1% concentration. Hydroxypropyl
methylcellulose and polyvinyl alcohol are also used as thickeners in ophthalmic solutions (Ansel 10:
616).
Compared with methylcellulose, hypromellose produces aqueous solutions of greater clarity, with
fewer undissolved fibers present, and is therefore preferred in formulations for ophthalmic use.
Hypromellose at concentrations between 0.45–1.0% w/w may be added as a thickening agent to
vehicles for eye drops and artificial tear solutions (Excipients: 327).
HPMC is commonly used to increase the viscosity of ophthalmic solutions and suspensions.
Although they reduce surface tension signifivcantly, their primary benefit is to increase the ocular
contact time, thereby decreasing the drainage rate and increasing drug bioavailability (Modern
Pharmaceutics 4: 459).
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Nama Bahan 2
D. Dasar Pemilihan Bahan Kemas Primer (5)
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E. Dasar Pemilihan Metode Sterilisasi (5)
C. Dasar Penentuan Spesifikasi Sediaan (3)

Spesifikasi 1
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Spesifikasi 2
Spesifikasi 3
Spesifikasi 4
Halaman 24 dari 42
Bagian 6 Informasi Bahan Aktif
A. Uraian Farmakologi
No. Item Uraian

1 Nama
2 Kelas farmakologi
3 Indikasi
4 Mekanisme kerja
5 Kontraindikasi
6 Efek samping
Umum :
Karsinogenesis :
7 Toksisitas
Tratogenesis :
Mutagenesis :
8 Dosis dan pemberian
9 Interaksi obat
10 Farmakokinetika
Halaman 25 dari 42
No. Item Uraian
B. Data Fisikokimia Bahan Aktif
No. Item Uraian
1 Nama
2 Nama IUPAC (…)
3 Rumus Molekul (…)
4 Berat Molekul (…)
Bentuk (…)
Warna (…)
5 Pemerian
Bau (…)
Rasa (…)
Titik Lebur (…)
Profil Termal (Dalam
6 Titik Didih (…)
Keadaan Padat)
Suhu Dekomposisi (…)
Dalam Air (…)
7 Kelarutan
Dalam Pelarut Lain (…)
8 pKa (…)
9 pH (Dalam Larutan) (…)
10 Koefisien Partisi (…)
11 Log P (…)
12 Polimorfisme (…)
13 Bentuk Kristal (…)
14 Higroskopisitas (…)
15 Ukuran Partikel (…)
Nyata (…)
16 Kerapatan Ruah (…)
Mampat (…)
Halaman 26 dari 42
No. Item Uraian
17 Rumus Bangun (…)
Halaman 27 dari 42
B. Data Fisikokimia Bahan Aktif (Lanjutan)
Spektrum, Termogram dan Fotomikrograf

17 Spektrum Serapan UV-Visible (…)
18 Spektrum Inframerah (…)
19 Termogram (DSC) (…)
Halaman 28 dari 42
Spektrum, Termogram dan Fotomikrograf

20 Termogram (TGA) (…)
21 Difraktogram Sinar-X (…)
22 Fotomikrograf (SEM) (…)
Halaman 29 dari 42
C. Uraian Stabilitas
No. Item Uraian
A Dalam Keadaan Padat (1)

1 Pengaruh Suhu (…)
2 Pengaruh Cahaya (…)
3 Pengaruh Kelembaban (…)
B Dalam Larutan (3)
1 Pengaruh Pelarut (…)
2 Pengaruh pH (…)
3 Pengaruh Cahaya (…)
C Inkompatibilitas (1)
1 Gugus Fungsi (…)
2 Ion Logam (…)
3 Senyawa Tertentu (…)
D Saran Penyimpanan (1)
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Bagian 7 Informasi Bahan Tambahan
A. Bahan Tambahan 1
No. Item Uraian
1 Nama
2 Nama IUPAC (…)
Bentuk (…)
Warna (…)
5 Pemerian
Bau (…)
Rasa (…)
6 Titik Lebur (…)
Dalam Air (…)
7 Kelarutan
8 pKa (…)
11 Stabilitas (…)
12 Inkompatibilitas (…)
13 Penanganan (…)
14 Toksisitas (…)
15 Saran Penyimpanan (…)
16 Konsentrasi (…)
B. Bahan Tambahan 2
No. Item Uraian
1 Nama
2 Nama IUPAC (…)
Bentuk (…)
5 Pemerian
Warna (…)
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No. Item Uraian
Bau (…)
Rasa (…)
6 Titik Lebur (…)
Dalam Air (…)
7 Kelarutan
8 pKa (…)
11 Stabilitas (…)
13 Penanganan (…)
14 Toksisitas (…)
C. Bahan Tambahan 3
No. Item Uraian
1 Nama
2 Nama IUPAC (…)
Bentuk (…)
Warna (…)
5 Pemerian
Bau (…)
Rasa (…)
6 Titik Lebur (…)
Dalam Air (…)
7 Kelarutan
8 pKa (…)
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No. Item Uraian
11 Stabilitas (…)
13 Penanganan (…)
14 Toksisitas (…)
D. Bahan Tambahan 4
No. Item Uraian
1 Nama
2 Nama IUPAC (…)
Bentuk (…)
Warna (…)
5 Pemerian
Bau (…)
Rasa (…)
6 Titik Lebur (…)
Dalam Air (…)
7 Kelarutan
8 pKa (…)
11 Stabilitas (…)
13 Penanganan (…)
14 Toksisitas (…)
E. Bahan Tambahan 5
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No. Item Uraian
1 Nama
2 Nama IUPAC (…)
Bentuk (…)
Warna (…)
5 Pemerian
Bau (…)
Rasa (…)
6 Titik Lebur (…)
Dalam Air (…)
7 Kelarutan
8 pKa (…)
11 Stabilitas (…)
13 Penanganan (…)
14 Toksisitas (…)
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Bagian 8 Peralatan, CPPs dan Sterilisasi

A. Peralatan
No. ID Alat Nama Alat/Tipe Merek Jumlah No.SOP
1 SOP-LABFARSET.01.001
2
3
4
5
6
7
8
9
10
B. Critical Process Parameters (CPPs)

Parameter QA* yang
Tahap Bahan Alat Syarat
Kritis Berhubungan
Prep
Mix
Filtr
Fill-Seal
PostSter
Pack
Catatan:
*QA: Quality Attribute
Prep: Preparasi/Sterilisasi; Mix: Mixing; Filtr: Filtrasi; Fill-Seal: Filling dan Sealing; PostSter: Sterilisasi Akhir; Pack: Pengemasan Primer
C. Sterilisasi
ID Alat/
No. Nama Alat/Bahan Metode Sterilisasi Ref.
Bahan
1
2
3
4
5
6
7
8
9
10 - Produk Akhir
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Bagian 9 Rancangan Spesifikasi Sediaan dan Rujukan Metode Pemeriksaan
No. Kriteria Ref Spesifikasi Ref Rujukan Metode

FISIKA
KIMIA
MIKROBIOLOGI
Halaman 36 dari 42
Bagian 10 Rancangan Pengemasan
No. Rincian
Kemasan Primer (No. Rancangan: 17BKP.A1.001-XXXXX)
Jenis :
1 Bahan :
Ketebalan :
Dimensi :
Bobot : per luas area
Kemasan Sekunder (No. Rancangan: 17BKS.A1.001-XXXXX)
Jenis :
2 Bahan :
Dimensi :
Volume :
Leaflet (No. Rancangan: 17LFT.A1.001-XXXXX)
Jenis :
3 Bahan :
Ketebalan :
Dimensi :
Label (No. Rancangan: 17LBL.A1.001-XXXXX)
4 Jenis :
Bahan :
Dimensi :
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Bagian 11 Perhitungan dan BoM
A. Rincian Perhitungan Tonisitas
B. Rincian Perhitungan Kapasitas Dapar
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C. Perhitungan Bahan
D. Bill of Material
Besar Bets = …. gram
Per Butir Per Bets

Item
Nama Bahan Fungsi
No
Jumlah UoM Jumlah UoM
Botol Kaca Tipe II BKP
Rubber Stopper (No Leg) BKP
Aluminium Cap BKS
Label BKS
Brosur BKS
Folding Box BKS
BKP = Bahan Kemas Primer; BKS = Bahan Kemas Sekunder

Rincian Perhitungan:
Halaman 39 dari 42
Bagian 12 Rancangan Proses Produksi
Tahap A Penyiapan Bahan Baku dan Bahan Kemas
Tahap B Penyiapan dan Sterilisasi Bahan Kemas Primer
Tahap C Preparasi dan Sterilisasi Alat/Bahan
Tahap D Pencampuran
Tahap E Filtrasi
Tahap F Pengisian dan Penyegelan
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Tahap G Sterilisasi Akhir
Tahap H Pemberian Label
Tahap I Pengemasan Sekunder
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Bagian 13 Referensi
1. Jones. D. FASTtrack: Pharmaceutics – Dosage Form and Design. London. Pharmaceutical Press.2008
2. Abate, M dan Abel, S. k. Remington: The Science and Practice of Pharmacy. Philadelphia: University
of The Sciences.2006
3. Gad, Shayne C. Pharmaceutical Manufacturing Hanbook: Production and Processes. Canada: Street
Hooboken. 2008.
4. Gibson M. Pharmaceutical Preformulation and Formulation. 2nd ed. Gibson M, editor. Florida: IHS
Health Group; 2004.
5. Katzung, Bertram G. Basic and Clinical Pharmacology 10th edition. McGraw-Hill. New York. 2006
6. Sweetman, Sean C . Martindale thirty sixth edition. London : Pharmaceutical Press.2009
7. Rowe, Raymond C,et al. 2009. Handbook of Pharmaceutical Excipients 6th Edition. UK:
Pharmaceutical Press.
8. Lachman, L., and Lieerman, H.A., and kanig , J.L., Teori dan Praktek Farmasi Industri. Universitas
Indonesia : Jakarta. Jilid 3. 1986
9. AHFS Drug Information. American Society of Health System Pharmacist. 2004.
10. Bhople, Amit, etc. Formulation and Development of Ketorolac Tromethamine Ophthalmic Solution.
India: Journal of Bioequivalence & Bioavailability. 2013.
11. AHFS Drug Information. American Society of Health System Pharmacist. 2011.
12. https://go.drugbank.com/drugs/DB09145
13. https://go.drugbank.com/salts/DBSALT001045
14.
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Laboratorium Farmasetika

DOKUMEN RANCANGAN PENGEMBANGAN PRODUK

PT. FARSET LABS.

1. Formulation Development Scientist #1 : Achmad Himawan/N111 07 038

TINJAUAN TERHADAP PRODUK REFERENSI/PRODUK PEMBANDING

Bagian 1 Identitas Produk

No. Item Uraian

3 Kandungan Bahan Aktif

Bagian 2 Quality Target Product Profile (QTPP)

No. Elemen QTPP Target Justifikasi

Bagian 3 Quality Attribute (Drug Product)

No. Quality Attribute Target Justifikasi

Bagian 4 Rancangan Formula

Tiap 10 ml sediaan mengandung:

Ketorolac 0,5% (ZA)fix

Bagian 5 Dasar Formulasi

A. Dasar Pembuatan Sediaan (5)

B. Dasar Pemilihan Bahan Aktif (3) dan Kekuatan Sediaan (3)

Ketorolac tromethamine shares the toxic potentials of nonsteroidal anti-inflammatory agents

inflammatory and analgesic. It is indicated Ketorolac tromethamine ophthalmic solution is

C. Dasar Pemilihan Bahan Tambahan (4)

Sodium chloride is widely used in a variety of parenteral and nonparenteral pharmaceutical

formulations; an exception is for preparations to be used during surgery or in the treatment of

Disodium fosfat (Buffer fosfat)

Purified water (pembawa)

D. Dasar Pemilihan Bahan Kemas Primer (5)

E. Dasar Pemilihan Metode Sterilisasi (5)

C. Dasar Penentuan Spesifikasi Sediaan (3)

Bagian 6 Informasi Bahan Aktif

No. Item Uraian

8 Dosis dan pemberian

No. Item Uraian

B. Data Fisikokimia Bahan Aktif

No. Item Uraian

No. Item Uraian

17 Rumus Bangun (…)

B. Data Fisikokimia Bahan Aktif (Lanjutan)

Spektrum, Termogram dan Fotomikrograf

18 Spektrum Inframerah (…)

19 Termogram (DSC) (…)

Spektrum, Termogram dan Fotomikrograf

21 Difraktogram Sinar-X (…)

22 Fotomikrograf (SEM) (…)

No. Item Uraian

A Dalam Keadaan Padat (1)

Bagian 7 Informasi Bahan Tambahan

No. Item Uraian

No. Item Uraian

No. Item Uraian

No. Item Uraian

No. Item Uraian

No. Item Uraian

No. Item Uraian

Bagian 8 Peralatan, CPPs dan Sterilisasi

B. Critical Process Parameters (CPPs)

Bagian 9 Rancangan Spesifikasi Sediaan dan Rujukan Metode Pemeriksaan

No. Kriteria Ref Spesifikasi Ref Rujukan Metode

Bagian 10 Rancangan Pengemasan

Bagian 11 Perhitungan dan BoM

A. Rincian Perhitungan Tonisitas

B. Rincian Perhitungan Kapasitas Dapar

Per Butir Per Bets

Botol Kaca Tipe II BKP