Preformulation Halal Raw Materials and Test

Question 1

The overall concept of preformulation is

Answer 1

to gather enough data in order to develop a chemically
stable and therapeutically effective drug product that can be commercially produced at large
scale.

Question 2

API with impurities will always be rejected. T/F

Answer 2

F. API with impurities is not always necessary to be rejected, provided that the impurity is completely characterized.

Question 3

What impurities in formulation need to be concerned?

Answer 3

The major concern is that impurities can affect product stability. Impurity is often found to be carcinogenic in nature, e.g. aromatic amine (p- amino phenol). ​

Question 4

What are some of the analytical method used?

Answer 4

ELISA, UV-Vis, TLC, HPLC

Question 5

What is the importance of preformulation testing in view of pharmaceutical product development? ​

Answer 5

1. to investigate the physical, chemical, and mechanical properties of a drug substance to develop a safe, effective, and stable dosage form.
2. the first step in the rational formulation of an active pharmaceutical ingredient (API)

Question 6

Why is the majority of existing drug candidates as well as emerging NCEs are lipophilic ?

Answer 6

1. high crystallinity/melting point and molecular weight of the drug
2. lack of ionisable groups present in the molecule

Question 7

An API has a Log P value of 3. Is it suitable for solid dosage form?

Answer 7

Yes. For a sufficient amount of
any drug absorption, its Log P value should be in the range of 1 to 3. When Log P is greater
than 6 or less than 3 it means they have poor transport characteristics.

Question 8

Is there any relation between pH and solubility? ​

Answer 8

The unionized species are highly lipid-soluble and result in high absorption through biological
membrane.
the solubility of weakly acidic or basic drug will depend upon pH, which in turn will influence the extent to which drug enters the blood stream, its
absorption and activity.

Question 9

Explain why sometimes drug excipient compatibility study by DSC may be misleading.

Answer 9

DSC is a thermal method.If the drug is thermolabile, it may show incompatibility with any excipient at
elevated temperature, but in reality the drug may not undergo that stressed condition

Question 10

Is it possible to design a tablet dosage form with hygroscopic drug?

Answer 10

Depending on the hygroscopicity of the drug, suitable moisture-proof coating and storage in a
low-humidity environment or in a special packaging with a desiccant can be adopted

Question 11

How to check the halalness of the API?​

Answer 11

1. each raw material used in the formulation need to have a halal certificate recognised by the religious authority
2. to have the material endorsed by the halal
   committee within the organisation,

Question 12

excipients are also supposed to be inactive chemically. However, this is not always true. why?

Answer 12

Excipients may contain active functional groups which may initiate some kind of chemical reaction with the API.​