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Authorities (including FDA) and pharmacopeias (including USP) never establish quality of products!

Reasons:

(1) They do not define quality of the products, hence it cannot be measured and/or established (link).
(2) Suggested methods and procedures lack scientifically relevancy and validity (link)
(3) GMP practices, including inspections, are about operation of manufacturing not per se reflection of products quality (link).

Developing discriminatory dissolution tests: Who invented this nonsense [fake-science]?

A discriminatory test in general is a test or procedure which would measure a given parameter and would be able to differentiate/discriminate such between tested objects where the differences exist. A common and simple example of such procedure or routine is monitoring body temperature using a thermometer. A thermometer is placed, usually in mouth, and after bit of wait, the thermometer would provide body temperature reading. Thermometers are pre-standardized/calibrated against reference standards (temperatures). There is no thermometer or monitoring procedure developments, no discriminatory test/procedure development, no “life-cycle” variations in procedures, and no subject dependent (gender, age, race, body weight/type) procedures. Note that thermometer does not even tell if the person has fever, it only will tell body temperature which is interpreted whether the person has fever or not. Point being a pre-standardized/calibrated thermometer by default becomes a discriminatory test or tester. This is how life/science works.

Similarly, a pre-standardized/calibrated dissolution test/tester must provide a drug dissolution/release characteristic of a product (tablet/capsule). Placing a product into a vessel equipped with a stirrer with pre-set rpm containing pre-defined solvent, its volume and temperature is the dissolution test/tester. Determining drug release after pre-defined time would provide the answer i.e. drug dissolution characteristics of the product. Period! There should absolutely be no need or requirements of dissolution methods development of any type at the product/formulation development and/or their evaluation stages.

Why do we have or need dissolution method development practices including discriminatory methods – pure ignorance and incompetency of the subject. This is simply nonsense and fake-science! Be clear that at present no one is determining dissolution characteristics of any product hence its quality for which this test is conducted and promoted.

Seek sensible and scientifically valid solutions! (1, 2, 3, 4)

There is no possibility of establishing quality of products without fixing the pharmacopeial drug dissolution test!

Quality of a drug product, such as tablet and capsule, may be defined as product’s ability to release the drug in humans in expected amount and with consistently. In technical term, it is known as drug release characteristics of the product. At the manufacturing stage, this characteristic is established by conducting an in vitro test commonly known as drug dissolution/release test. The test is commonly conducted as recommended by regulatory agencies (such as FDA) and pharmacopeias (such as USP) using paddle and basket apparatuses. The quality assessment of most of the solid dosage forms, if not all, in particular tablet and capsule products is determined using this test.

The testers for this test, however, have never been validated for the intended purpose. Therefore, conclusions drawn from this test, hence quality of the products, would be invalid and false. Use caution in accepting and/or making claims about quality of products! (link)

Seek help for conducting a scientifically valid drug dissolution test and establishing quality of the drug products.

Sink condition – an invalid and unscientific concept and requirement!

Drug dissolution testers, in particular most commonly recommended ones (paddle and basket), are based on closed system/environment i.e. without a drain, therefore, it is not possible to have or create a sink condition. Authorities and pharmacopeias require it while “experts” create it. How? Magic!

In addition, one does not even require a sink condition for in vitro drug dissolution testing. 900 ml of water with or without a small amount of solubilizer sufficient to (freely) dissolve the expected amount of drug present in the product – is all one needs. For further details please follow the link here to simplify your life and avoid wasting time and resources (link).

Quality Fraud!

One cannot avoid being part of it. It is the regulatory agencies’ (e.g. FDA) and pharmacopeias’ (such as USP) practices and requirements to use the non-validated/non-qualified (hence non-GMP) testers and tests causing the fraud. Any claim with respect to quality of the products, in particular tablet and capsule for both brand-name and generic products, has to be false.

Blaming and punishing the industry for product quality and manufacturing are not relevant or valid and would not help. Education, advice and help are needed at the authorities and pharmacopeias in defining quality and setting its standards and specifications (1, 2).

I will be happy to explain the issues with quality assessments in detail and can provide solutions to address them (link).

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