Ibuprofen 200mg Soft Capsules PL 03105/0105 UKPAR

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1 Ibuprofen 200mg Soft Capsules PL 03105/0105 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken for assessment Page 13 Summary of Product Characteristics Page 14 Patient Information Leaflet Page 15 Labelling Page 16 1

2 LAY SUMMARY Ibuprofen 200mg Soft Capsules (ibuprofen, soft capsules, 200mg) This is a summary of the Public Assessment Report (PAR) for Ibuprofen 200mg Soft Capsules (PL 03105/0105). It explains how Ibuprofen 200mg Soft Capsules were assessed and their authorisation recommended, as well as their conditions of use. It is not intended to provide practical advice on how to use Ibuprofen 200mg Soft Capsules. For practical information about using Ibuprofen 200mg Soft Capsules, patients should read the package leaflet or contact their doctor or pharmacist. What are Ibuprofen 200mg Soft Capsules and what are they used for? Ibuprofen 200mg Soft Capsules contain the active substance, ibuprofen, which belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDS). Ibuprofen 200mg Soft Capsules are used for the relief of: headache and migraine pain; dental pain and neuralgia; period pain; rheumatic, muscular and back pain; feverish and symptoms of cold and flu. Ibuprofen 200mg Soft Capsules are a generic medicine. This means that Ibuprofen 200mg Soft Capsules are similar to reference medicines already authorised in the European Union (EU) called Nurofen 200 mg Tablets (Crookes Healthcare Limited, UK) and Nurofen 200 mg Liquicaps (Crookes Healthcare Limited, UK). How are Ibuprofen 200mg Soft Capsules used? Ibuprofen 200mg Soft Capsules can be obtained without a prescription, at pharmacies, supermarkets and other retail outlets without the supervision of a pharmacist. The recommended dose for adults, the elderly and children aged 12 years and older is 1 or 2 capsules to be taken by mouth with water, up to three times a day as required. There should be at least four hours between doses. No more than 6 capsules should be taken in 24 hours. Ibuprofen 200mg Soft Capsules are for short term use. The capsules should not be taken for longer than 10 days unless advised to do so by a doctor. If symptoms persist or pain or fever worsens, or if any new symptoms occur, a doctor or pharmacist should be consulted. Ibuprofen 200mg Soft Capsules should not be given to children under 12 years old. For further information on how Ibuprofen 200mg Soft Capsules are used, refer to the package leaflet and Summary of Product Characteristics available on the MHRA website. How do Ibuprofen 200mg Soft Capsules work? The active substance, ibuprofen, provides relief by changing the body s response to pain, swelling and high fever. 2

3 How have Ibuprofen 200mg Soft Capsules been studied? As Ibuprofen 200mg Soft Capsules are a generic medicine, studies in patients have been limited to bioequivalence tests to determine that they are similar to the reference medicine, Nurofen 200 mg Liquicaps (Crookes Healthcare Limited, UK). Two medicines are bioequivalent when they produce the same levels of the active substance in the body. In addition, the applicant (Bell, Sons & Company (Druggists) Limited) provided data from the published literature on ibuprofen. What are the benefits and risks of Ibuprofen 200mg Soft Capsules? Because Ibuprofen 200 mg Soft Capsules are a generic medicine that is bioequivalent to the reference medicine, their benefits and risks are taken as being the same as those of the reference medicine. Why are Ibuprofen 200mg Soft Capsules approved? It was concluded that, in accordance with EU requirements, Ibuprofen 200mg Soft Capsules have been shown to have comparable quality and to be bioequivalent to Nurofen 200 mg Liquicaps (Crookes Healthcare Limited, UK). Therefore, the view was that, as for Nurofen 200 mg Liquicaps (Crookes Healthcare Limited, UK), the benefit outweighs the identified risk. What measures are being taken to ensure the safe and effective use of Ibuprofen 200mg Soft Capsules? A Risk Management Plan has been developed to ensure that Ibuprofen 200mg Soft Capsules are used as safely as possible. Based on this plan, safety information has been included in the Summary of Product Characteristics and the package leaflet for Ibuprofen 200mg Soft Capsules, including the appropriate precautions to be followed by healthcare professionals and patients. Other information about Ibuprofen 200mg Soft Capsules. A Marketing Authorisation was granted in the UK on 17 April The full PAR for Ibuprofen 200mg Soft Capsules follows this summary. For more information about treatment with Ibuprofen 200mg Soft Capsules, read the package leaflet, or contact your doctor or pharmacist. This summary was last updated in June

4 Ibuprofen 200mg Soft Capsules PL 03105/0105 SCIENTIFIC DISCUSSION TABLE OF CONTENTS Introduction Page 5 Pharmaceutical Assessment Page 6 Non-clinical Assessment Page 9 Clinical Assessment Page 10 Overall Conclusion and Benefit/Risk Assessment Page 12 4

5 INTRODUCTION Based on the review of the data on quality, safety and efficacy, the Medicines and Healthcare products Regulatory Agency (MHRA) granted Bell, Sons & Company (Druggists) Limited a Marketing Authorisation for the medicinal product Ibuprofen 200mg Soft Capsules (PL 03105/0105). The product is a General Sales Licence (GSL) medicine and is indicated in adults and children over 12 years for the symptomatic relief of: rheumatic or muscular pain; backache; neuralgia; migraine; headache; dental pain; dysmenorrhoea; feverishness; colds and influenza symptoms. The application was submitted under Article 10(1) of Directive 2001/83/EC, as amended, cross-referring to Nurofen 200 mg Tablets which were authorised in the UK to Crookes Healthcare Limited on 06 May The application also refers to the bioequivalence study reference product, Nurofen 200mg Liquicaps (Crookes Healthcare Limited, UK), which was granted in the UK on 31 January 2008 and subsequently underwent a change of ownership procedure to Reckitt Benckiser Limited on 25 January The active ingredient, ibuprofen, is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic properties. One bioequivalence study was submitted to support this application comparing the applicant s test product Ibuprofen 200 mg Soft Capsules with the reference product Nurofen 200mg Liquicaps (Crookes Healthcare Limited, UK), under fasting conditions. The applicant has stated that the bioequivalence study was conducted in compliance with European Guidelines, International Conference on Harmonisation (ICH) Good Clinical Practices (GCP) Guidelines and the Declaration of Helsinki. With the exception of the bioequivalence study, no new non-clinical or clinical data were submitted, which is acceptable given that this application was based on the product being a generic medicinal product of an originator product that has been in clinical use for over 10 years. No new or unexpected safety concerns arose during review of information provided by the Marketing Authorisation Holder and it was, therefore, judged that the benefits of taking Ibuprofen 200mg Soft Capsules outweigh the risks and a Marketing Authorisation was granted. 5

6 PHARMACEUTICAL ASSESSMENT ACTIVE SUBSTANCE INN: Ibuprofen Chemical name: (±)-p- isobutylhydratropic acid (±)-2-(p-isobutylphenyl) propionic acid IUPAC: 2-[4-(2-methylpropyl)phenyl]propanoic acid Structure: Molecular formula: C 13 H 18 O 2 Molecular weight: Appearance: White to off-white, crystalline powder Solubility Practically insoluble in water; very soluble in alcohol, acetone, methanol and in chloroform; slightly soluble in ethyl acetate. Ibuprofen is the subject of a European Pharmacopoeia monograph. All aspects of the manufacture and control of the active substance, ibuprofen, are covered by a European Directorate for the Quality of Medicines and Healthcare (EDQM) Certificate of Suitability. DRUG PRODUCT Other Ingredients Other ingredients consist of the pharmaceutical excipients in the capsule and capsule shell namely Macrogol 400, sorbitan mono-oleate, sorbitol, potassium hydroxide (E525), purified water, gelatin (E441), Ponceau 4 R red (E124), triglycerides medium chain, shellac (glaze), titanium dioxide (E171) and propylene glycol. Appropriate justification for the inclusion of each excipient has been provided. All excipients comply with their respective Pharmacopoeia monographs, with the exception of shellac, which complies with a suitable in-house specification. Satisfactory Certificates of Analysis have been provided for all excipients, showing compliance with the proposed specifications. With the exception of gelatin, none of the excipients contain materials of animal or human origin. The supplier of gelatin has provided a Certificate of Suitability from the European Directorate for the Quality of Medicines and Healthcare (EDQM) to show that it is manufactured in line with current European guidelines concerning the minimising of risk of transmission of Bovine Spongiform Encephalopathy/Transmissible Spongiform Encephalopathies (BSE/TSE). No genetically modified organisms (GMO) have been used in the preparation of these excipients. 6

7 Pharmaceutical Development The objective of the development programme was to formulate a safe efficacious, stable dosage form (soft capsule) bioequivalent to the reference product Nurofen 200 mg Liquicaps (Crooke Healthcare Limited, UK). Suitable pharmaceutical development data have been provided for this application. Comparable in-vitro dissolution profiles have been provided for this product and the reference product. Manufacturing Process A satisfactory batch formula has been provided for the manufacture of the product, along with an appropriate account of the manufacturing process. The manufacturing process has been validated with pilot-scale batches and has shown satisfactory results. The Marketing Authorisation Holder has committed to performing process validation studies on future full-scale production batches. Control of Finished Product The finished product specification is satisfactory. Test methods have been described and adequately validated, as appropriate. Batch data have been provided that comply with the release specification. Certificates of Analysis have been provided for any working standards used. Container Closure System The product is packed in polyvinylchloride/aluminium-polyvinylidene chloride/aluminium (PVC/Alu and PVDC/Alu) blisters packed with the Patient Information Leaflet in outer cartons in pack sizes of 10, 12 and 16 soft capsules. Not all pack sizes may be marketed. Satisfactory specifications and Certificates of Analysis have been provided for all packaging components. All primary packaging complies with the current European regulations concerning materials in contact with food. Stability Finished product stability studies were performed in accordance with current guidelines on batches of finished product packed in the packaging proposed for marketing. The data from these studies support a shelf-life of 3 years, with the special storage conditions Store below 25 C. Store in the original pack. Suitable post approval stability commitments have been provided to continue stability studies on batches of finished product. Bioequivalence Satisfactory Certificates of Analysis have been provided for the test and reference batches used in the bioequivalence study. Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and Labelling The SmPC, PIL and labelling are satisfactory from a pharmaceutical perspective. A package leaflet has been submitted to the MHRA along with results of consultations with target patient groups ( user testing ), in accordance with Article 59 of Council Directive 2001/83/EC, as amended. The results indicate that the package leaflet is well-structured and organised, easy to understand and written in a comprehensive manner. The test shows that the patients/users are able to act upon the information that it contains. 7

8 MAA (Marketing Authorisation Application) Form The MAA form is satisfactory from a pharmaceutical perspective. Expert Report (Quality Overall Summary) The quality overall summary is written by an appropriately qualified person and is a suitable summary of the pharmaceutical aspects of the dossier. Conclusion The grant of a Marketing Authorisation is recommended. 8

9 NON-CLINICAL ASSESSMENT PHARMACODYNAMICS, PHARMACOKINETICS AND TOXICOLOGY As the pharmacodynamic, pharmacokinetic and toxicological properties of ibuprofen are well-known, no further non-clinical studies are required and none have been provided. NON-CLINICAL EXPERT REPORT (NON-CLINICAL OVERVIEW) The applicant s non-clinical overview has been written by an appropriately qualified person and is satisfactory, providing an appropriate review of the relevant non-clinical pharmacology, pharmacokinetics and toxicology. ENVIRONMENTAL RISK ASSESSMENT As the product is intended for generic substitution with a product that is already marketed, no increase in environmental burden is anticipated. Thus, non-submission of an Environmental Risk Assessment is accepted. CONCLUSION The grant of a Marketing Authorisation is recommended. 9

10 CLINICAL ASSESSMENT CLINICAL PHARMACOLOGY The clinical pharmacology of ibuprofen is well-known. With the exception of data from the bioequivalence study detailed below, no new pharmacodynamic or pharmacokinetic data are provided or are required for this application. Pharmacokinetics In support of this application, the applicant submitted the following bioequivalence study: A randomised, open label, two-treatment, two-sequence, two-period, single-dose, crossover study to compare the pharmacokinetics of the applicant s test product Ibuprofen 200 mg Soft Capsules versus the reference product Nurofen (Ibuprofen soft gelatin capsules) 200 mg Liquicaps (Crookes Healthcare Limited, UK) in healthy adult male and female subjects under fasting conditions. The subjects were administered a single dose (one 200 mg capsule) of either the test or the reference product with 240 ml of water, after at least a 10-hour overnight fast. Blood samples were collected before and up to and including 24 hours after each administration. The washout period between the treatment phases was 7 days. The pharmacokinetic results are presented below: Pharmacokinetic parameters (geometric means, ratios and confidence intervals [CI]) for ibuprofen Test (A) Ibuprofen 200 mg Soft Capsules (Bell, Sons & Co (Druggists) Limited) Reference (B) Nurofen 200 mg Liquicaps (Crookes Healthcare Limited, UK) C max maximum plasma concentration AUC 0-t area under the plasma concentration-time curve from time zero to t hours area under the plasma concentration-time curve from time zero to infinity hours AUC 0-inf Conclusion The 90% confidence intervals of the test/reference ratio for AUC 0-t, and C max lie within the acceptable limits of 80.00% to %, in line with the Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev 1/Corr**). Thus, the data support the claim that the applicant s test product is bioequivalent to the reference product Nurofen 200 mg Liquicaps (Crookes Healthcare Limited, UK) under fasting conditions. EFFICACY The efficacy of ibuprofen is well-known. No new efficacy data have been submitted and none are required for this type of application. 10

11 SAFETY With the exception of the safety data generated during the bioequivalence study no new safety data were submitted and none are required for this type of application. No new or unexpected safety issues were raised during the bioequivalence study. PHARMACOVIGILANCE SYSTEM AND RISK MANAGEMENT PLAN The Pharmacovigilance System, as described by the applicant, fulfils the requirements and provides adequate evidence that the applicant has the services of a qualified person responsible for pharmacovigilance, and has the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country. An acceptable Risk Management Plan for the product has been submitted. The following table lists the summary of safety concerns which have been identified: Appropriate pharmacovigilance and risk minimisation activities have been addressed. SUMMARY OF PRODUCT CHARACTERISTICS (SmPC), PATIENT INFORMATION LEAFLET (PIL) AND LABELLING The SmPC, PIL and labelling are acceptable from a clinical perspective. The SmPC is consistent with that for the reference product. The PIL is consistent with the details in the SmPC and in line with current guidance. The labelling is also in line with current guidance. CLINICAL EXPERT REPORT (CLINICAL OVERVIEW) The clinical overview is written by an appropriately qualified physician and is a suitable summary of the clinical aspects of the dossier. CONCLUSION The grant of a Marketing Authorisation is recommended. 11

12 OVERALL CONCLUSION AND BENEFIT/RISK ASSESSMENT QUALITY The important quality characteristics of Ibuprofen 200mg Soft Capsules are well-defined and controlled. The specifications and batch analytical results indicate consistency from batch to batch. There are no outstanding quality issues that would have a negative impact on the benefit/risk balance. NON-CLINICAL No new non-clinical data were submitted. As the pharmacokinetics, pharmacodynamics and toxicology of ibuprofen are well-known, no additional data were required. EFFICACY With the exception of the bioequivalence study, no new data were submitted and none are required for this type of application. Bioequivalence has been demonstrated between the applicant s product and the reference product Nurofen 200 mg Liquicaps (Crookes Healthcare Limited, UK) under fasting conditions. SAFETY With the exception of the safety data from the bioequivalence study, no new data were submitted and none are required for this type of application. As the safety profile of ibuprofen is well-known, no additional data were required. No new or unexpected safety concerns arose from the bioequivalence study. PRODUCT LITERATURE The SmPC, PIL and labelling are satisfactory and in line with current guidance. BENEFIT/RISK ASSESSMENT The quality of the product is acceptable, and no new non-clinical or clinical safety concerns have been identified. Extensive clinical experience with ibuprofen is considered to have demonstrated the therapeutic value of the compound. The benefit/risk balance is, therefore, considered to be positive. 12

13 Ibuprofen 200mg soft Capsules PL 03105/0105 STEPS TAKEN FOR ASSESSMENT 1 The MHRA received the Marketing Authorisation application on 20 November Following standard checks and communication with the applicant the MHRA considered the application valid on 06 December Following assessment of the application the MHRA requested further information relating to the dossier on 29 July 2013, 10 February 2014 and 21 March The applicant responded to the MHRA s requests, providing further information on the dossier on 10 January 2014, 17 February 2014 and 25 March The application was granted on 17 April

14 SUMMARY OF PRODUCT CHARACTERISTICS In accordance with Directive 2010/84/EU, the Summaries of Product Characteristics (SmPCs) for products granted Marketing Authorisations at a national level are available on the MHRA website. 14

15 PATIENT INFORMATION LEAFLET In accordance with Directive 2010/84/EU, the Patient Information Leaflets (PILs) for products granted Marketing Authorisations at a national level are available on the MHRA website. 15

16 LABELLING 16

17 17

18 18

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