Formula N Analisis

PREFORMULATION, FORMULATION, PACKAGING, & ANALITYCAL METHOD OF DRUG
Click to edit Master M. AKBAR EMBERIK subtitle style (260112110062) TONI FATONI (260112110064) MITA OLIVINA (260112110066) FEBRINA AMELIA SAPUTRI (260112110068) MARINA SUSANTI (260112110070)
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PREFORMULATION
A phase of a research and development process where the pre formulation scientist characterizes the physical, chemical and mechanical properties of a new drug substance Powerpoint Templates in order to develop stable, safe and
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WHY PREFORMULATION IMPORTANT ?
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GOALS OF PREFORMULATION
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PREFORMULATION
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EVALUATED PARAMETER
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CONT
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E x c i p i e n t
TABLET FORMULATION
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DISINTEGRANT (1)
Disintegrant are added to facilitate the breaking of tablet when in contact with the fluids of the gastrointestinal tract, may have a function to bind a water, so the tablet will expand and broke to constituent part so as to release the drug and cause the effect.
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DISINTEGRANT (2)
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B i n d e r g i v e
BINDER
a
LUBRICANT
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PACKAGING
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T h e
INTRODUCTION
p a c k a g i n g
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PACKAGING MATERIAL
used as a barrier to protect the pharmaceutical preparations against external factors that can degrade them and consequently decrease their effectiveness and increase toxic effects
TYPE OF PACKAGING MATERIAL
to assure the therapeutic effectiveness 17 Powerpoint Templates Page
Solid oral dosage forms generally need to be protected from the potential adverse effects of the following:
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[ F o o d
QUALITY CONTROL OF PACKAGING MATERIAL
a n d
D r u g
An important step in such evaluations is characterization of the packaging materials and the chemicals that can migrate or extract from container closure Powerpoint Templates Page system components to the drug 19
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FDA s guidance document requires the evaluation of four attributes to establish suitability:
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TABLETS PREPARATION TEST

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OFFICIAL STANDARD TABLET PREPARATION TESTING
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BP
Uniformity of weight Active ingredients Uniformity (BBPP) Disintegran Dissolution (some) of content
USP
Variations in weight Determination (assay) uniformity of content Disintegran Dissolution (some)
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TOLERANCE OF TABLETS VARIAN WEIGHT

Pharmacopeia BP Weight of tablet (mg) < 80 80-250 > 250 USP < 130 130-234 > 324 PH Eropa < 13 13-130 > 130 10% of difference (n-2) 10 7,5 5 10 7,5 5 15 10 7,5 Powerpoint Templates No defference (n-0) 15 12,5 10 20 15 10 15
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CONTENT UNIFORMITY
Pharmacopea BP. F Eropa Dose Limit ( % ) N 10 1 0 < 2 mg or < 2 % b/b 85-115 If < 85>115 Then 75-125
Because of that 85-115 30 < 85>115 75-125 USP commonly use As above 2 1 10
RSD < 6,0 RSD <7,8
10 30
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DISINTEGRATION
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DISINTEGRATION TEST
Time and condition BP Not coated tablet coated : thin layer sugar enteric Eferfesen Soluble Dispersible USP Not coated tablet Coated tablet Enterik buccal Sublingual <15 minutes <30 minutes <60 minutes in 0,1 N HCl >120 minutes in 0,2 N HCl <60 minutes PH 6,8 ( phosphat ) <5 minutes in 200 ml of water, 20o C <3 minutes <3 minutes 2 tablets in 100 ml of water, dispersed, through the 710 m <time of monograph <time of monograph undamage for 60 minutes in simulated gastric fluid, and disintegrated in the simulated intestinal fluid <time of monograph <4 hours Powerpoint Templates <time of monograph Page 30 Type of tablet
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THE NONCOMPENDIAL PROPERTIES

1. HARDNESS TESTS
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T e n s i l e
2. TENSILE STRENGTH
s t r e n
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3. FRIABILITY
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W o r k
4. Work of Failure
o f f a i l u r e
Wf=2>p.dx/DT
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E q 5. u Three Point Bend a t i F = 3f / 4dT2 . (Mpa) o n f o r t

where: P = load at failure (kP) f = distance between the two tablets (the fulcrum) d = diameter of the smallest and the form of tablets T = thickness of the tablet
6. Tablet Diameter (score)
With the application of three-point test can be performed indentation testing tabletsthe requirements of halved tablets tablet) Tables for are used for half (score (diameter). Properties Description or one quarter. Diameter> 7.5 <12 mm size
form profile line formulation style tense stiffness Coated thin-layer Pillows> capsule> oval>>> circular Thin (3:1), average In (1 mm), the form V Brittle (plastic, too stiff) <1 MPa at 8 mm <4 J
Powerpoint Templates cracks Promote brittle
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7. The Nature of The Surface (Indentation)
Tablet structure is anisotropic. Strength, porosity, and disintegration friability influenced by the porosity. Varies along the surface and the thickness of the tablet. Friction on the surface layer produces a more tightly. To prevent this, added magnesium stearate. Identity is a measure of resistance against plasticPowerpoint Templates deformation,
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D R U G
CONTENT UNIFORMITY TESTING
A N A L Y S I S
UV-VISIBLE SPECTROPHOTOMETRY
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EQUIPMENTS OF UV-VISIBLE SPECTROPHOTOMETRY
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CIRCUIT EQUIPMENT OF UV-VISIBLE SPECTROPHOTOMETRY
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High Performance Liquid Chromatography (HPLC)
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CIRCUIT EQUIPMENT OF HPLC
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GAS CHROMATOGRAPHY
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CIRCUIT EQUIPMENT OF GAS CHROMATOGRAPHY
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F a c t o r s t h a t a f f e c t e
SOURCES OF ERROR IN THE MEASUREMENT
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S y s t e m a t i c
SYSTEMATIC ERROR (SYSTEMATIC ERROR)
e r r o r
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In general, factors that become sources of error in the measurements, giving rise to variations in the results, include: 1. Differences found on the object being measured. This can be overcome by: a. Object to be analyzed is treated in such a way as to obtain a homogeneous quality measures b. Use traditional sampling techniques properly and correctly
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2 . S i t u a t i o n
Contd
a t
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Formula N Analisis

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PREFORMULATION, FORMULATION, PACKAGING, & ANALITYCAL METHOD OF DRUG

WHY PREFORMULATION IMPORTANT ?

Click to edit Master subtitle style

TYPE OF PACKAGING MATERIAL

to assure the therapeutic effectiveness 17 Powerpoint Templates Page

QUALITY CONTROL OF PACKAGING MATERIAL

TABLETS PREPARATION TEST

OFFICIAL STANDARD TABLET PREPARATION TESTING

TOLERANCE OF TABLETS VARIAN WEIGHT

RSD < 6,0 RSD <7,8

THE NONCOMPENDIAL PROPERTIES

E q 5. u Three Point Bend a t i F = 3f / 4dT2 . (Mpa) o n f o r t

6. Tablet Diameter (score)

Powerpoint Templates cracks Promote brittle

7. The Nature of The Surface (Indentation)

CONTENT UNIFORMITY TESTING

EQUIPMENTS OF UV-VISIBLE SPECTROPHOTOMETRY

CIRCUIT EQUIPMENT OF UV-VISIBLE SPECTROPHOTOMETRY

High Performance Liquid Chromatography (HPLC)

CIRCUIT EQUIPMENT OF HPLC

CIRCUIT EQUIPMENT OF GAS CHROMATOGRAPHY

SOURCES OF ERROR IN THE MEASUREMENT

SYSTEMATIC ERROR (SYSTEMATIC ERROR)

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