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การน าเภสัชต ารับมาใช้ในการพิจารณาจัดท าคุณลักษณะเฉพาะของยา

รองศาสตราจารย์ เภสัชกร ดร.พรชัย โรจน์สิทธิศกัดิ์ รองคณบดีฝ่ายวิจัย และอาจารย์ประจ าภาควิชาอาหารและเภสชัเคมี

และ เภสัชกร วรธัช ฐิติกรพงศ์

นักวิจัยประจ าศูนย์นวัตกรรมทางยาและผลิตภัณฑ์สุขภาพ คณะเภสัชศาสตร์ จุฬาลงกรณ์มหาวิทยาลัย

ความรู้และความเข้าใจแนวทางการจัดท าคุณลักษณะเฉพาะยาและเกณฑ์การประเมินค่าประสิทธิภาพต่อราคา ส าหรับเภสัชกรผู้ปฏิบัติงานด้านการคัดเลือก จัดซื้อจัดหายาในโรงพยาบาล กระทรวงสาธารณสุข

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REGULATIONS

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OFFICIAL PHARMACOPOEIA USP

• General Notices and requirements

• General Chapters

• Dietary Supplements Chapters

• Reagents

• Reference Tables

• Dietary Supplements

• NF Monographs

• USP Monographs

3

GENERAL NOTICES AND

REQUIREMENTS

The General Notices and Requirements section presents the basic assumptions, definitions, and default conditions for the interpretation and application of the USP and NF.

4

GENERAL CHAPTERS

5

GENERAL CHAPTERS

6

GENERAL CHAPTERS

Guide for

Noncomplex Active

Drug substance

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DIETARY SUPPLEMENTS

CHAPTERS

8

REAGENTS, INDICATORS

AND SOLUTIONS

9

REFERENCE TABLES

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DIETARY SUPPLEMENTS

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NF MONOGRAPHS

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USP MONOGRAPHS

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USP MONOGRAPH COMPONENTS

1. Title

2. Definition

3. Description and solubility

4. Identity

5. Assay

6. Impurities and foreign substances

7. Performance tests

8. Specific tests

9. Additional requirements

General Notices USP 37 14

USP MONOGRAPH OF DRUG SUBSTANCES (AMOXICILLIN)

Title

Definition

Identification 15


Cont.

ASSAY

16


Cont.

Impurities

17


Cont.

Specific test

18


Cont.

Additional

Requirements

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USP MONOGRAPH OF DRUG PRODUCTS (AMOXICILLIN CAPSULES)

Title

Definition

Identification

20


ASSAY

Cont.

21


Performance

test

Cont.

22


Specific test

Additional

requirements

Cont.

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รศ. ภก. ดร. พรชัย โรจน์สิทธิศักดิ์, ภก. วรธัช ฐิติกรพงศ์

1. TITLE

ความรู้และความเข้าใจแนวทางการจัดท าคุณลักษณะเฉพาะยาและเกณฑก์ารประเมินค่าประสิทธิภาพต่อราคา ส าหรับเภสัชกรผู้ปฏิบตัิงานด้านการคัดเลือก จัดซื้อจัดหายาในโรงพยาบาล กระทรวงสาธารณสุข

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TITLE

Drug substance Drug product

• Drug’s Name

• chemical formula and Structure

• Molecular weight

• Nomenclature

• pure, diluted active substance,

combination

• Forms: base, salt, anhydrous,

hydrate, solvate

• Drug’s Name and dosage form

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EXAMPLE (DRUG SUBSTANCE)

Drug’s name

chemical structure

MW

Molecular

formula

26

Base form

Drug substance

27

Diclofenac

Salt form

Drug substance

28

Diclofenac Sodium Diclofenac Potassium

Hydrate form

Drug substance

Amoxicillin trihydrate

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Drug Product

Tier one:

Route of

Administration

Tier two:

Dosage form and Physical

properties

Tier three:

Type of Release

pattern

Tier Four:

Comprehensive

testing strategy

Gastro-Intestinal Aerosols Capsule Immediate

By Injection Dry powder inhaler Emulsion (creams,

lotions)

Extended

Mucosal Foams Medical gases Delayed

Topical Dermal Gels Granules

Inhalation Medicated gum Implants

Inserts Liquids

Lozenges Ointments

Pastes Transdermal system

(patches)

Pellets Pills

Plasters Powder

Medicated soaps and

shampoos

Solutions

Sprays Suppositories

Suspension Tablets

Tapes 30

Drug Product

31


2. DEFINITION


32

DEFINITION Drug substance Drug product

• Percentage of drug substance

• Calculated based on

• the as-is basis

• the dried basis

• the anhydrous basis

• the ignited basis

• Packaging and storage

requirements

• % Labeled amount

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CALCULATION EQUATION

% based on the as-is basis Q/T x 100

% based on the dried basis [Q/T/(100-LOD/100)] x 100 LOD = %Loss on drying

% based on the anhydrous basis [Q/T/(100-W/100)] x 100 W = % water content

% based on the ignited basis [Q/T/(100-I/100)] x 100 I = % Loss on ignition

% based on the anhydrous and

solvent-free basis [Q/T/(100-A-B)/100] x 100 A = % water content, B = solvent free content

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% BASED ON THE DRIED BASIS

35

[Q/T/(100-LOD/100)] x 100

% BASED ON THE ANHYDROUS BASIS

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[Q/T/(100-W/100)] x 100

% BASED ON THE IGINTED BASIS

37

[Q/T/(100-I/100)] x 100

% BASED ON THE ANHYDROUS AND SOLVENT-FREE BASIS

38

[Q/T/(100-A-B)/100] x 100


3. DESCRIPTION AND SOLUBILITY


39

DESCRIPTION AND SOLUBILITY

Acetaminophen: white,

odorless, crystalline

powder, having a slightly

bitter taste. Freely soluble

in alcohol; soluble in

boiling water and in 1N

sodium hydroxide.

40


4. IDENTIFICATION


41

IDENTIFICATION

• Identification – Organic Nitrogenous Bases

• Identification Tests – General

• Identification --- Tetracyclines

• Spectrophotometric Identification Tests

• Thin-Layer Chromatographic Identification Test

• Fats and Fixed oils

• Titrimetry

• Chromatography

• Loss on drying

• X-ray Fluorescence Spectroscopy

• Mass spectrometry

• Nuclear Magnetic Resonance Spectroscopy

• Optical Rotation

• Spectrophotometry and Light-Scattering

• Characterization of Crystalline and Partially Crystalline Solids by X-Ray

Powder Diffraction (XRPD)

• Near-Infrared Spectroscopy

• Raman spectroscopy

• Applications of Nuclear Magnetic Resonance Spectroscopy

42

IDENTIFICATION

IR spectrum of amoxicillin

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5. ASSAY


44

ASSAY • USP reference Standards

• Antibiotics --- Microbial Assays

• Assay for Steroids

• Barbiturate Assay

• Ephedrine Assay

• Iodometric Assay --- Antibiotics

• Nitrite Titration

• Single-Steroid Assay

• Titrimetry

• Chromatography

• X-ray Fluorescence Spectroscopy

• Mass spectrometry

• Polarography

• Spectrophotometry and Light-scattering

• Raman spectroscopy 45

ASSAY

Acceptance criteria

46


6. IMPURITIES AND FOREIGN SUBSTANCE


47

IMPURITIES AND FOREIGN SUBSTANCES

Organic impurities

(process- and drug- related)

• Starting materials

• By products

• Intermediates

• Degradation products

• Reagents, ligands, and catalysts

• Geometric and Stereoisomerism

Inorganic impurities

• Reagents, ligands, and catalysts

• Heavy metals or other residual metals

• Inorganic salts

• Other materials (e.g. filter aids, charcoal)

Residual Solvent

• Organic liquids used as vehicles for the preparation of solutions or suspensions in the synthesis of a drug substance.

• Residual solvents

Drug substance

Impurities 48


USP 37

Organic impurities

49


USP 37


50


USP 37


Loss on ignition

51


7. PERFORMANCE TEST


52

PERFORMANCE TEST

Uniformity of dosage units Dissolution

Drug Product

Uniformity of dosage unit is defined as the

degree of uniformity in the amount of the

drug substance among dosage units.

The test is provided to

determine whether tablets

or capsules disintegrate

within the prescribed time

when place in a liquid

medium at the experimental

conditions presented below.

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Uniformity of

dosage units

The term “uniformity of

dosage unit” is defined

as the degree of

uniformity in the amount

of the drug substance

among dosage units.

Demonstrated by one of the follows;

(1) Content uniformity

(2) Weight variation

54

DISSOLUTION

This test is provided

to determine

compliance with the

dissolution

requirements for

dosage forms

administered orally.

55


8. SPECIFIC TEST


56

SPECIFIC TEST

Physicochemical Characterization Water content

• porosity by nitrogen adsorption-desorption

• Bulk Density and Tapped Density

• Color and Achromicity

• Crystallinity

• Density of Solids

• Loss on drying

• X-Ray Fluorescence Spectrometry

• Melting Range or Temperature

• Nuclear Magnetic Resonance Spectroscopy

• Optical Microscopy

• Optical Rotation

• Osmolality and Osmolarity

• pH

• Powder Fineness

• Refractive Index

• Specific gravity

• Microbiological Examination of Nonsterile Products:

Microbial Enumeration test

• Microbiological Examination of Nonsterile Products:

Tests for Specified Microorganisms

• Bacterial Endotoxin Test

• Sterility Tests

• Titrimetry

• Loss on drying

• Thermal Analysis

• Water Determination

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9. ADDITIONAL REQUIREMENT


58

ADDITIONAL REQUIREMENTS

• Preservation

• Packaging ,

• Storage

• Labeling

• USP Reference Standard

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THANK YOU FOR ATTENTION

ขอบขอบคุณ ภาควิชาอาหารและเภสัชเคมี

คณะเภสัชศาสตร์ จุฬาลงกรณ์มหาวิทยาลัย ศูนย์นวัตกรรมทางยาและผลิตภัณฑ์สุขภาพ

แห่งจุฬาลงกรณ์มหาวิทยาลัย

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