PHARM ANA

Any substance or combination of substances presented as having properties for treating or preventing disease in human beings/ and or animals. Closely resembles drug definition

Medical product / Drug product

Medical product / Drug product is any substance or combination of substances that may be used in or administered to human beings and/or animals with a view either restoring, correcting or modifying physiological functions by exerting a ___, ___, or ___, or to making a ___.

pharmacological, immunological, metabolic action, medical diagnosis

___+ ___ = MEDICAL PRODUCT

API

EXCIPIENT

also medical products but the difference is that these lack clinical trials

Food and health supplements

Any substance or combination thereof, intended to be used for manufacturing of a medical product

API

API aims to:

○ Furnish a pharmacologic activity in the diagnosis, cure, mitigation, treatment or prevention of disease

○ Affect the structure and function of the body

Any constituent of a medicinal product that is inactive. Should ideally be ___

Excipient

inert

Excipient is intended for:

○ Ensure ease of use and production.

○ Ensure absorption of API

○ Ensure preparation has an acceptable shelf-life

○ Ensure good palatability

is defined as the process in which different chemical substances, including active ingredient and excipients, are combined to produce a final medical product. It aims to develop a preparation that is both stable, and acceptable to the patient (in terms of ___)

Formulation

good bioavailability

___ was once indicated for ___ but later on was discovered to have hair growth properties.

Minoxidil

HPN (hypertension)

A branch of analytical chemistry that uses various techniques to evaluate the quality, safety, and efficacy of pharmaceutical products

Pharmaceutical analysis

Involves a series of processes for the identification, determination, quantitation, and purification of substances or combination of substances.

Pharmaceutical analysis

Pharmaceutical analysis is the main function of ___ in the field of ___

Quality Control

industrial pharmacy

what are the difference of Pharmaceutical analysis and Analytical chem?

Analytical chem focuses on biological specimens

defined as the needs of the patient with regards to their medication therapy needs.

Pharmaceutical care

Pharmaceutical care four distinct components:

○ The medication is appropriate

○ The medication is safe

○ The medication is effective

○ The patient is adherent/compliant

contracted for transfer of technology. These companies manufacture products for other companies.

Toll manufacturers

Pharmaceutical care in systems level

Pharmaceutical care in patient level

Totality features. Conformance to standards and specifications

Quality

The manufacturer’s internally-made requirements for the product and approved by regulatory bodies.

Specifications

The official requirements and for raw materials and finished product. Specification for the general use

Standards / Monograph

collection of monograph

compendia

A wide-ranging concept, which covers all matters that influence quality of the product. Oversees the manufacturing firm. This includes ___

Quality Assurance

Auditing

Ensures consistency and control of products produced through appropriate quality standards and specifications. Has ___ (but focuses more on ___). This includes ___

Good Manufacturing Practice

9 chapters

production

Performance evaluation

Part of the GMP concerned with sampling, specifications and testing, and with the organization, documentation and release procedures.

Quality Control

Monograph/standards include

identity

strength/potency

purity

performance

To identify if the API is the medicine that it claims to be

Identity

To quantify the labelled claim

Strength/Potency

To determine the impurities that may be present in a medicine.

Purity

To predict and demonstrate the pharmacokinetics of a medicine. Involved in ___

Performance

FPQC

document that is given after QC is completed which shows all the total tests done in the batch sample

Certificate of analysis

Input, process, output cycle

Assures that policies are followed. Cooperates with ___ (e.g., PIC/S, GMP, GLP, FDA, etc.) FPQG. Prepares the ___. Perform ___. ___-based

QA

regulatory agencies

Quality Manual and SOPs

Audit and Monitoring

Process-based

Tests compliance of raw materials, and packaging materials. Perform ___. Monitors environmental procedures. ___-based

QC

in-process quality control (IPQC), raw material quality control (RMQC), and finished product quality control (FPQC)

Product-based

Validation Parameters includes:

Accuracy

Precision

a test if it is fit for its intended use

ANALYTICAL VALIDATION PARAMETERS

Refers to the closeness of test results to the true value

Accuracy

Degree of agreement among individual tests when the method is applied repeatedly to multiple samplings of a homogenous sample

Precision

types of precision

INTRA-ASSAY PRECISION

INTRA-LABORATORY PRECISION

INTER-LABORATORY PRECISION

Sample repeatability. ex: Weighing, dilution, extraction

INTRA-ASSAY PRECISION (diff lab; repeatability)

Intermediate Precision. ex: Different operators, instruments, reagents

INTRA-LABORATORY PRECISION (within the same lab)

Reproducibility. ex: Proficiency testing inter lab studies, Long term stability studies, blind sample determination. Where transfer of technology happens

INTER-LABORATORY PRECISION (reproducibility)

Capacity to remain unaffected by deliberate variations in methods

Robustness/ Rigidity (ruggedness)

Ability to assess the analyte in the presence of other substances. What sets it apart, assesses purity

Specificity

Ability to discriminate between small differences in analyte concentration

Sensitivity

Produce results directly proportional to the concentration of the analyte

Linearity

Lowest and highest concentration of your analyte where you can produce accurate, precise and linear results.

Range

2 methods for test of impurities

LOD: limit of detection

LOQ: limit of quantitation

Reveals the identity of the elements and compounds in a sample. Presence or absence of a component. ex: Phytochemical screening

Qualitative Analysis

Indicates the amount/ concentration/ potency of each substance in the sample. Aka?

Quantitative Analysis

ASSAY

Amount of Sample

Ultramicro ( < 1 mg)

Micro (1-10 mg)

Semimicro/Meso (10-100 mg)

Macro (> 100 mg)

Amount of Sample (Analyte level)

Major (1-100%)

Minor (0.1-1%)

Trace (100 ppb -100 ppm)

Ultratrace ( < 100 ppb)

2 types of sample desired

Proximate Analysis

Ultimate Analysis

identifying a class/group of substances ■ ex: assay of flavonoid content in plants

Proximate Analysis

identifying a specific substance/compound. ex: total caffeine assay test, carbon content of gasoline, atropine content of deadly nightshade

Ultimate Analysis

3 types of material

Chemical - chemical reactions/reagents

Biological - living organisms/systems

Physical - particle size, melting/boiling point / help of instruments

Nature of Method

Classical - Titrimetry (general or chemical method)

Instrumental - UV-Vis (based on physical)

Special/Miscellaneous - moisture content (water content for crude drugs)

Identity Tests

Physical Method - specific gravity, refractive index, optical rotation

Chemical Method - visible reactions

Gross Physical Appearance - organoleptic

Limit Tests

Gross Impurities - gross dirt, insoluble matter

Chemical Impurities - trace metals, ion, degradation products

Biological Impurities - viable microbes (specific to non-specific strains), metabolic products

Potency

Instrumental Methods - HPLC, UV Spectro, Gas Chromatography

Chemical - Titrimetric

Biological Method - live animals, excised organs or tissues, biological products such as proteins, blood

Packaging

Material type – plastic, glass

Special properties – transparent, collapsible, easy to drain

Integrity – lightness, bulk-free

Dosage-Form Specific Tests

Tablets, capsules – dissolution, disintegration

Implants – disintegration

Parenteral – BET/ LAL, tonicity test

visible reactions, detection of incidences of adulteration (debasement/lowering the quality of article)

Chemical

Addition of inferior material

Sophistication/true adulteration

Entirely different from one requested

Substitution

Add through accident, ignorance, carelessness

Admixture

Quality destroyed by microorganism

Spoilage

Quality impaired due to environment, insects, etc.

Deterioration

assessment of the material based on physical properties

Physical

ratio of density of a substance to that of a reference substance at a specified volume and temperature • Evaluated using a ___.

Specific Gravity

pycnometer

description of how light propagates through a medium • measured within a controlled wavelength and temperature • using an ___ • for liquid dosage forms

Refractive Index

ABBE refractometer

ability of the substance to rotate plane polarized light • measure in the angle of rotation that may be positive or negative • Evaluated using a ___. • Remember racemic mixtures (50:50 right and left enantiomers)

Optical Activity

polarimeter

capacity of a solute to dissolve in a solvent in a specific temperature and pressure • Parts of solvent required to dissolve 1 part of solute

Solubility

it is the maximum temperature at which a substance transitions from a solid to a liquid state

Melting point

it is the maximum temperature at which a substance transitions from a liquid to a gas state

Boiling point

the use of analytical equipment to determine the properties of a materia

Instrumental

uses wavenumbers to identify the functional groups present in a substance

Infrared Spectroscopy

Infrared Spectroscopy identify functional groups

primary apparatus

Infrared Spectroscopy (shaking of atoms)

vibratory

Infrared Spectroscopy: ___ are directly proportional to transmittance

wavenumbers

primarily uses the ___ as well as absorption intensities in the characterization of the substance • used for ___ identification • ___ (produces colors)

UV-Vis Spectroscopy

absorption maxima and minima

secondary

excitation

In UV-Vis Spectroscopy, ___ is directly proportional to absorbance but inversely proportional to ___

absorption maxima

transmittance

In UV-Vis Spectroscopy, ___ is inversely proportional to absorbance

transmittance

uses the ___ in a plate either made of cellulose with an appropriate support ■ the intensity and color of the spots is directly proportional to ___

Thin Layer Chromatography

Rf value

concentration

uses the ___ in the characterization of the substance

High Performance Liquid Chromatography

retention time

through a ___; if there is an increase in concentration, color intensity also ___

Thin Layer Chromatography

densitometer

increases

use of animals

Biologic Assay

used for antimicrobial substances and preservatives. either ___ or ___

Microbial Assay

Cylinder Plate Method

Turbidimetric Method

Animals Used in Testing of Drugs

substance used to prevent microbial growth

Preservatives

the most common human skin yeast

Candida albicans

major air and soil fungal contaminant

Aspergillus niger

the most common gram (-) fermentative enteric bacteria

Escherichia coli

the most common water-borne gram (-) non-fermentative bacteria

Pseudomonas aeruginosa

the most common gram (+) bacterial pathogen

Staphylococcus aureus

Allowable content: Should be ___

Limit Tests

less than 1 ppm

Determines the amount of volatile matter of any kind that is driven of under the conditions specified

Loss on Drying (LOD)

Water Content Determination

Method I: Titrimetry (Karl Fischer Reagent)

Method II: Azeotropic Distillation (Toluene Moisture Apparatus)

Method III: Gravimetric (Convection oven)

Weigh pre-oven weight then measure after oven, times 100

Method III: Gravimetric (Convection oven)