Reference no: EM131175101

Q1. The homogeneity of the preparation is important.

a. What is meant by the concept of content variation (uniformity of content)?

b. How is the content variation test?

c. For measurements of the concentration variation of a tabletbatch found that batch did not pass the established thresholds according to the current pharmacopoeia. Describe in principle two different measures that can be taken to improve the content variation of tablet formulation.

d. Mention another tablet property where there is a requirement of the Pharmacopoeia.

Q2. When mixing powder differentiates between different types of powder mixtures.

a. Describe what is meant by a random mixture or an ordered mixture.

b. ordered mixtures has certain advantages in formulation of solid preparations which?

Q3. Amorphous and crystalline materials often differ on material and tablet properties. Explain how these properties are affected if a material goes from being crystalline to become amorphous. Compare e.g. crystalline and amorphous lactose.

a. Tablet Strength

b. Dissolution rate

Q4. The question concerns the mechanical properties of materials.

a) How is the parameter Young's modulus?

b) How is the Young's modulus affected by the following parameters? Motivate your answer.

- Size

- Moisture

- Porosity

c) How important is the material's mechanical properties tablet strength?

Q5. The question is Extemporaneous medicines.

a. You will produce 100 ml of oral fluid with the following composition.

Propranolol 1 mg / ml

Propranololihydrochloridum 1 mg

Syrup sacchari 320 mg

Acidumcitricummonohydricum 2.8 mg

Natriicitras 2.1 mg

Aqua purificata ad 1 ml

Processing's density is 1.075 g / cm3. The preparation should be preserved with a total 0.1% metagin. You should use a diluenda of metagin (Dil. Methylis parahydroxybenzoatis 10%). Syrup sacchari used in the formulation are already preserved with 0.1% metagin. Calculate the amount of components. Show your calculations.

b. The above were made on August 28 2016. What is the expiration date on preparation provided by the general shelf life extemporeberedningar case? Enter the expiration date in the year and month.

c. In the manufacture of the oral fluid propranolol 1 mg / ml is used Aqua pura. In the manufacture of sterile preparations used instead Aqua ad injectabilia. What distinguishes these waters for the production?

d. You will manufacture 100 pieces capsules with the following composition:

1 capsule contains:

Calciilactaspentahydricus RESPOND Ca2 + 20 mg

Lactosumq.s.

Molecular weights:

Calciilactaspentahydricus: 308

Calcium: 40

Calculate the amount of salt Calciilactaspentahydricus to be added. Show your calculations.

Q6. Describe the principle of the osmotic controlled drug release from a tablet.