B32C08 Laboratory Studies in Pharmaceutical Sciences Student Name: Student Number:

Practical Pharmaceutical Microbiology Laboratory Report Proforma

Practical Group No.: Practical Group Team Members:

Complete the following sections as instructed, adhering closely to the word count stated; the marks for each section are clearly indicated. Zero marks will be awarded if the word limit is exceeded more than 5% or if there is evidence of plagiarism from the practical handbook or other source. Reports must be typed, DO NOT change the order in which the text boxes appear (you can make them bigger if necessary) and use Arial font 10. Submit the completed th document on Monday 7 February 2011 to the School of Pharmacy office. INTRODUCTION Discuss the sources of contamination in the pharmaceutical industry and how they are controlled. Why is this important in the manufacture of pharmaceuticals? (800 words max; 10 marks).

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AIMS Write a summary of the main aims of the practical (300 words max; 3 marks).

METHODS Write an experimental overview for practical sessions 2-6 (i.e. experiments conducted with the contaminated medicines). You should include names of tests you conducted but DO NOT write a description of the scientific principles behind each assay (500 words max; 5 marks).

Description of Pharmaceutical Products Used: In session 2, you were provided with two contaminated pharmaceutical products (A & B). Write here all the information that was provided on the labels and record the appearance of the contaminated product in comparison to the uncontaminated medicine (300 words max; 2 marks).

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RESULTS 1 Identification of bacterial contaminants in a medicine: In sessions 3 & 4, you undertook a series of tests to identify bacterial contaminants in two medicines. Complete the following table to summarise your findings (3 marks). Biochemical Assay Colony Morphology Gram Status CatalaseTest Oxidase Test Starch Test Mannitol Salt Agar Test CitrateTest MacConkey Agar Test Sugars: Glucose Lactose Glycerol Mannose Sucrose Write a brief summary of the significance of these results and finally state which bacteria were identified. Comment on how well the data between the above tests and API strips correlated (500 words max; 5 marks). Contaminant A Contaminant B

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RESULTS 2 The effect of antimicrobials on microbial growth: In sessions 5 & 6 you undertook a series of tests to investigate the effectiveness of a variety of antimicrobials on the growth of bacterial contaminants found in the medicines. Here you are asked to present your data here in graphical format and explain the significance of the findings. RESULTS 2A Determination of the inhibitory power of disinfectants. Insert your data in graphical format (4 marks). Explain the key findings from this experiment (400 words max; 4 marks).

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RESULTS 2B Antibacterial activity of creams and ointments. Insert your data in graphical format (4 marks). Explain the key findings from this experiment (400 words max; 4 marks).

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RESULTS 2C Antibacterial activity of medicated gauze dressings. Insert your data in graphical format (4 marks). Explain the key findings from this experiment (400 words max; 4 marks).

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RESULTS 2D Resistance of microorganisms towards antibiotics. Insert your data in graphical format (4 marks). Explain the key findings from this experiment (400 words max; 4 marks).

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RESULTS 2E Effect of temperature on microbial growth. Insert your data in tabular format (2 marks). Explain the key findings from this experiment (300 words; 2 marks).

RESULTS 2F Effect of preservatives on microbial growth. Insert your data in tabular format (2 marks). Explain the key findings from this experiment (300 words; 2 marks).

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APPENDIX 1 - Details of antimicrobials used. Complete the table below with details of the batch numbers, active ingredients and working concentrations (including units) of all the antimicrobials you used in these experiments (8 marks). Experiment 1 - Determination of the inhibitory power of disinfectants towards bacteria Disinfectant Batch Number Active ingredient(s) Stock Concentration (units) Working concentration (units) Trigene Antiseptic Hand Gel Antiseptic Hand Soap Hand soap Dettol Spray

Experiment 2 - Antibacterial activity of creams and ointments Cream/Ointment Batch Number Active ingredient(s) Working concentration (units) Acriflex Dilute Acriflex Cetrimide Savlon Cream Base

Experiment 3 - Antibacterial activity of samples of medicated gauze dressings Medicated gauze Batch Number Active ingredient(s) Actisorb Bactigras Inadine

Experiment 4 - Resistance of microorganisms towards antibiotics Antibiotic Batch / LOT Number Working concentration (units) Tet Nit Chl Cot Amp Pen Gen Ery

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CONCLUSIONS Briefly summarise the aims of the above experiments and the key findings. Based on your results from these practical sessions describe the approaches you would take to prevent contamination from these organisms happening again during the manufacturing process. (800 words max; 10 marks)

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REFERENCES Include relevant and published full references ONLY using an accepted format (DO NOT exceed 1 page; 4 marks).

APPENDIX 2 - MHRA YELLOWCARD (10 marks) MHRA Yellowcards are used by patients and health professionals to report suspected adverse drug reactions (ADRs) and you are asked to complete one here (DO NOT submit this to the MHRA). You will need the following information to complete the form found on the following pages; write this assuming you are a qualified pharmacist and a patient has come in to see you describing ill health following taking Medicine A. The affected patients typically experienced serious adverse effects, specifically: vomiting, diarrhoea and pyrexia. All of these effects started a few hours after taking the medicine on the date that it was obtained. In all cases, the patients returned to the pharmacy the following day and returned the suspected medicine. They were not taking any other medicines. All affected patients have now made a complete recovery; however, they were significantly incapacitated for 2-3 days. On the Yellowcard you will need to state the treatment given to the patient. Use the data determined by your group in sessions 5 and 6 to determine which antimicrobial would be the most effective to treat the above symptoms. Complete the form to the best of your ability for medicine A ONLY. You will need to make up some details; ensure the patient information is relevant according to the medicine taken.

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PATIENT DETAILS

Patient Initials:

Sex: M / F

Weight if known (kg):

Age (at time of reaction): SUSPECTED DRUG(S) Give brand name of drug and batch number if known Route Dosage

Identification (Your practice / Hospital Ref):

Date Started

Date Stopped

Prescribed For

SUSPECTED REACTION(S) Please describe the reaction(s) and any treatment given:

Date reaction(s) started:

Date reactions stopped: Yes / No

Outcome Recovered Recovering

Do you consider the reaction to be serious?

If yes, please indicate why the reaction is considered to be serious (please tick all that apply): Patient died due to reaction Life threatening Congenital abnormality

Involved or prolonged inpatient hospitalisation Involved persistent or significant disability or incapacity

Continuing Other

Medically significant; please give details:

Continued overleaf

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Please list other drugs taken in the last 3 months prior to the reaction (including self-medication & herbal remedies) Was the patient on any other medication? Drug (Brand, if known) Route Yes / No Dosage If yes, please give the following information if known: Date Started Date Stopped Prescribed for

Additional relevant information e.g. medical history, test results, known allergies, rechallenge (if performed), suspected drug interactions. For congenital abnormalities please state all other drugs taken during pregnancy and the date of last menstrual period.

REPORTER DETAILS Name and Professional Address:

CLINICIAN (if not the reporter) Name and Professional Address: Postcode:

Postcode: Tel. No.: Speciality: Signature:

Tel. No.: Speciality: If you would like information about other adverse reactions associated with the suspected drug, please tick this box

Date: If you report from an area served by a Yellow Card Centre (YCC), MHRA may ask the Centre to communicate with you, on its behalf, about your report. See BNF (page 11) for further details on YCCs. If you want only MHRA to contact you, please tick this box.

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