MANUF LAB M2.1 (Canvas)

Planning of Material Requirements, Liquid preparation, Filling and packing, Sales of drug product, Vendor handling, Customer service

Steps of Liquid Manufacturing

pharmaceutical elegance

The final preparation must satisfy the requirements of ______________ as it can affect the compliance of the patient

1. Concentration of reactants; 2. Temperature ; 3. Light/radiation ; 4. pH; 5. Choice of packaging

Instability can be caused by the following factors (5)

Glass ; Plastic; Metal; Rubber

The materials commonly employed as container components for pharmaceutical preparation include _______ (4)

Accelerated stability studies

Test or Studies that should be conducted to test degradation of product to temperature

Light / Radiation

This can cause degradation due to some complex chemical structure of drugs.

Co-solvency, pH Control, Solubilization, Complexation, Hydrotropy, Chemical modification of the drug

Specila techniques to aid solubility of poorly-soluble drugs

Co-solvency

Solubility is increased by using a water-miscible solvent, in which the drug has good solubility

Ethanol, Propylene glycol, Sorbitol, glycerin

Co-solvents used for co-solvency are the following (4)

Buffer systems

Serving as bulking agents in lyophilized formulation or can be used to control pH in solutions

Micelles

Solubilization can be achieved through the addition of surface active agents to form colloidal aggregates known as _______

EDTA and Citric Acid

Complexing agents examples (2)

Calcium + EDTA

A chelating agent that may exhibit microbial growth, as calcium is required for bacterial growth

Hydrotropy

Increase in the solubility of a substance, through the addition of additives, consisting of fairly high concentrations of alkali metal salts of various organic acid

Sodium benzoate, sodium citrate, urea, niacinamide

Examples of hydrotropes (4)

Chemical modification of the drug

The most commonly employed technique for the pure form of drugs converted to their corresponding water-soluble salt or ester forms

Certified colors

[Coloring Agents] synthetically produced

Certified colors

[Coloring Agents] they impart an intense, uniform color

Certified colors

[Coloring Agents] less expensive

Certified colors

[Coloring Agents] blend more easily to create a variety of hues

Certified colors

[Coloring Agents] generally do not add undesirable flavors to foods

Dyes

[Coloring Agents] dissolve in water, but are not soluble in oil

Dyes

[Coloring Agents] manufactured as powders, granules, liquids

Dyes

[Coloring Agents] have side effects which lakes do not (large amounts of such ingested can color stools)

(Aluminum) Lake pigments

[Coloring Agents] are made by combining dyes with salts to make insoluble compounds

(Aluminum) Lake pigments

[Coloring Agents] tint by dispersion

(Aluminum) Lake pigments

[Coloring Agents] not oil soluble, but are oil dispersible

(Aluminum) Lake pigments

[Coloring Agents] more stable than dyes

(Aluminum) Lake pigments

[Coloring Agents] uses include coated tablets, lipsticks, soaps, shampoos, talc, etc.

PRESERVATIVES

Substances which prevent bacterial and fungal growth in liquid formulations

Effective against a broad-spectrum range of microbes; Physically, chemically and microbiologically stable until the expiry date of the product is reached; Non-toxic; Non-sensitizing; Adequately soluble; Compatible/acceptable to the taste and odor/color of the product

Antimicrobial Effectiveness Test (AET)

The USP presents standard protocols for assessing the relative efficacy of a preservative in a formulation using the _________

Acidic, Neutral/Alcohols, Mercurials, Quaternary Ammonium Compounds, Esters of p-hydroxybenzoic acid

Preservative groups (5)

Sucrose

Refined white sugar is also called as ____________

Saccharin sodium acesulfame potassium, stevia powder, xylitol, malitol, sucralose, monoammonium glyzirrhizinate, aspartame

Examples of Synthetic/Artificial Sweeteners

Adjunct to palatability; To improve drainage (pourability)

Viscosity-building agnets are desired to serve as _____________ (2)

PVP, Methyl cellulose, Carboxymethyl cellulose (CMC)

Examples of viscosity-controlling agents

Dilute solutions of hydrogen peroxide, phenol derivatives, and peracetic acid

Appropriate disinfectants for cleaning equipment include _________ (3)

Filtration system

It is a unit operation in which mixtures of liquids and solids, slurry or feed is forced through a porous medium, in which solids form a cake on the surface and the clear liquid is obtained

Characteristics of the liquid, type of package used, required production output

Considerations in filling of liquids (3)

Gravimetric method, Volumetric method, Constant Level method

Basic Filling Methods (3)

Gravimetric method

[Basic Filling Methods] Limited to very large containers and/or highly viscous liquid products

Gravimetric method

[Basic Filling Methods] When large quantities of liquid materials are handled, it is more convenient and accurate to adapt the ___________ of filling

Volumetric method

[Basic Filling Methods] Accomplished by pumping the liquid, at constant pressure, through the orifice of constant diameter and size, for a predetermined period of time

Constant level method

[Basic Filling Methods] Makes use of container height as the means of controlling the fill amount of each bottIle

Stress cracking tests, corrosion tests

Bottle caps and closures undergo _______ tests (2)

compatibility tests

Cap liners undergo ____________ tests

Torque testing

Adequate seal is evaluated by torque testing

Torque tester

An instrument designed to check the circular force required to open and close the closures; it checks the tightness of caps and closures