Phar1101 Pharmacy And Formulation Sciences:Validate Assessment Answer

1.

As part of your honours research lab-based project, you are required to validate an HPLC method for assaying a drug in capsules. Refer to the ICH and/or PIC/s website and answer the following questions:

1. Explain the role of PIC/s and the benefits to the pharmaceutical industry (in Australia) by the TGA joining PIC/s.
2. Briefly explain the ICH requirements to validate the HPLC assay of an active ingredient in the capsules in terms of precision.
3. The harmonised “Guide to good manufacturing practice for medicinal products” (Part 1 – developed by PIC/s on July 2018 - PE 009-14) has been adopted by the TGA. Briefly describe the role of QC in the GMP of the manufacture of medicine outlining two examples (processes) for QC.
4. Refer to the following diagram from Tyrer et al., 1970 (Outbreak of Anticonvulsant Intoxication in an Australian City – available in your reading list in module 1). Discuss how the root cause of the intoxication of phenytoin was identified and then explain how applying the GMP principles should avoid such incident. 

2.

Review the following case and then answer the following questions:

The Australian sponsor of specific tablets has been notified by the overseas manufacturer that distributed finished product has had minor non-compliances identified pertaining to marginally lower potency (assay) and dissolution times for the tablets during routine stability testing.
There is no health or safety risk to any patient/consumer if they take these goods. This recall action does not affect any other batches of these tablets. These batches have been distributed to pharmacies and warehouses. No injuries have occurred in Australia due to this and this matter is not considered to be safety related.

1. Explaining your selection, select an appropriate recall action for this incident.
2. Classify the recall action and justify your classification. 

3.

The UV-Visible spectrometer can be used in the pharmaceutical industry due to its simple use, relative affordability, and wide application. Answer the following questions:

1. Briefly explain the use of the UV-Visible spectrometer in the qualitative analysis of active pharmaceutical ingredients in medicine.
2. Outline the analytical steps needed to be taken when using the UV-Visible spectrometer to quantify a drug in medicine and briefly explain three factors that need to be considered to ensure accurate measurement from the instrument.
3. What is the concentration of drug X in a solution in (in mg per mL) if value for drug X is 500 at a specific wavelength and the measured absorbance was 0.250 at the same wavelength?
4. Calculate the percentage of stated content of drug X in tablets from the following information:

(i) Tablet powder containing about 80 mg of the drug is ground to a paste with 10 ml of 2 M HCl.

(ii) The paste is then diluted with 200 ml of water, shaken for 15 min and finally made up to 500 mL.

(iii) A portion of the extract is filtered.

(iv) 2.5 mL of the filtrate is taken and diluted to 50 ml with 0.1 M HCl.

(v) The absorbance is read at a wavelength of 251 nm.

Note the followings:

• value of drug X at 251 nm = 935
• Stated content of drug X per tablet = 50 mg
• Weight of 20 tablets = 1.650 g
• Weight of tablet powder taken for assay = 0.1360 g
• Absorbance reading = 0.500.

4.

Refer to the Table that summarises the requirements and sections of the TGO 101 that applies to different types of medicines (page 9 in Guidance for TGO 101 V1.1 February 2020 – Reading list for Module 3) and then answer the following questions:

1. Identify FOUR minimum requirements for Amoxilcapsules (500 mg) and describe the required criteria to pass each test.
2. If we are to do the uniformity of mass of single unit dose for Amoxil capsules, outline the steps needed to complete the test.
3. The assay of 10 individual capsules which were selected randomly from a batch of Amoxilcapsules (500 mg) was conducted and is shown in the table below. Answer the following questions:

1. Explaining your answer, state whether the batch of capsules pass/fail/need further testing for the uniformity of content. You need to explain your answer.
2. Showing your work and explaining your answer, state whether the same batch (results shown in the table above) pass/fail/need further testing for the uniformity of dosage unit.
3. Explain the two approaches for completing the uniformity of dosage unit and the conditions for applying each approach in your answer. Your answer should include an example medicine where each approach must be followed for the uniformity of dosage unit.

5.

Your pharmacy undertakes extemporaneous compounding regularly to meet the needs of your customers. To comply with the current Quality Care guidelines, your pharmacy has decided to undertake quality control (QC) tests of the products regularly compounded at the pharmacy.

You have chosen the salicylic acid and coal tar ointment as the product to be checked. Salicylic acid and coal tar ointment APF is prepared by using the following excipients.

1. You have decided to contact Professional Compounding Chemists of Australia (PCCA) to request QC testing of your products. Explain FOUR tests that PCCA will consider completing to meet QC requirements for the ointment that you have prepared. Your answer should include the importance of each test.
2. Texture probe analyser is frequently used in the quality assurance of pharmaceuticals. Explain THREE QC parameters that can be obtained from this instrument and outline how these parameters can be used to assure the quality of semi-solid formulations. Your answer should explain how these parameters are obtained i.e. experiment method and typical results obtained from this instrument.
3. Semi-solid dosage forms can be used to deliver medication via wide range of routes. Using topical drug delivery and ocular drug delivery as examples, explain how the quality control tests used for semi-solid dosage forms may differ depending on route of drug delivery.