7/30/2019 Norita - Pharmaceutical Engineering 5 - Exercise 1

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Norita

Pharmaceutical Engineering 5

1. Describe the characteristic of polymorph of active pharmaceutical ingredientsrelevant to formulation design and APIs bioavailability.

Polymorph is characterized as the ability of a drug substance to exist as two or more

crystalline phases that have different arrangements and/or conformations of the

molecules in the crystal lattice. The characteristics of polymorph relevant to

formulation design and APIs bioavailability are:

- Polymorph form will have different aqueous solubility and dissolution rates inform that differ in solid-state structure.

- Have a significant influence on the stability and bioavailability of the drugproduct.

- Polymorphs exhibit different physical and mechanical properties, such ashygroscopicity, flowability, and compactibility, which in turn may affect the

processing or manufacturing of a drug substance.

- Polymorphs of a pharmaceutical solid may have different physical and solid-statechemical reactivity properties. These differences based upon differences in

thermodynamic ability and in molecular mobility, particularly of an amorphous

form.

2. Describe the purpose of formulation designThe purposes of formulation design are:

To design and manufacture medicines that delivers the drug to the patient in therequired amount.

At the optimum rate necessary to achieve the desired therapeutic benefit withinliving dissolution and absorption

Consistently within lots which is blend uniformity for all components, betweenlots which is validated manufacturing process

For the shelf life of the product or stability To optimize their clinical effectiveness To enhance the quality of designed product and to improve the efficiency of the

design process.

7/30/2019 Norita - Pharmaceutical Engineering 5 - Exercise 1

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Norita

Pharmaceutical Engineering 5

3. Describe the relevant of stability study versus shelf life of pharmaceutical dosageform

The stability of the pharmaceutical dosage form should be monitored according to a

continuous appropriate programme that will permit the detection of any stability

issue changes in levels of impurities or dissolution profile) associated with the

formulation in its marketed container closure system. The purpose of the stability

programme is to monitor the product over its shelf life and to determine that the

product remains, and can be expected to remain, within specifications under the

labelled storage conditions.Stability can affect the functioning of the dosage form,

the role of packaging in relation to stability, and the estimation of the shelf life of

pharmaceutical dosage form. Shelf life is expiration dating period, conformance

period. The time period during which an API is expected to remain within the

approved shelf-life specification, provided that it is stored under the conditions

defined on the container label.

4. Describe the purpose of closures in parenteral dosage formThe purposes of a closure in parental dosage form are:

To allow easy access to a packaged product and to reclose the package, when thecontents are not used only for single serve.

Ensuring that the package has not been opened prior to the first opening by theconsumer, facilitating the dispensing of the product.

Supporting the brand equity value of the product. To keep the container closed and the contents contained for the specified shelf

life until time of opening.

Provide a barrier to dirt, oxygen and moisture. Provide a means of reclosing or reusing the container. Assist in dispensing and use of product.