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Lipid-Based Depots: Manufacturing, Administration and Interactions of Protein Drugs with Lipid Formulations
Dissertation zur Erlangung des Doktorgrades der Fakultät für Chemie und Pharmazie der Ludwig-Maximilians-Universität München Lipid-based depots: manufacturing, administration and interactions of protein drugs with lipid formulations Michaela Maria Breitsamer aus Starnberg, Deutschland 2019 II ERKLÄRUNG Diese Dissertation wurde im Sinne von § 7 der Promotionsordnung vom 28. November 2011 von Herrn Prof. Dr. Gerhard Winter betreut. EIDESSTATTLICHE VERSICHERUNG Diese Dissertation wurde eigenständig und ohne unerlaubte Hilfe erarbeitet. Wolfratshausen, den 20.05.2019 ________________________________ (Michaela Breitsamer) Dissertation eingereicht am: 20.05.2019 1. Gutachter: Prof. Dr. Gerhard Winter 2. Gutachter: Prof. Dr. Wolfgang Frieß Mündliche Prüfung am: 25.06.2019 III IV FOR MY FAMILY “The way to get started is to quit talking and begin doing” Walt Disney (1901 – 1966) V VI ACKNOWLEDGEMENTS The present thesis was prepared between March 2015 and December 2018 at the Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics at the Ludwig-Maximilians Universität (LMU) in Munich under the supervision of Prof. Dr. Gerhard Winter. First of all, I would like to express my deepest gratitude to my supervisor Prof. Dr. Gerhard Winter for giving me the opportunity to join his research group and to work on this extremely interesting and interdisciplinary project. I really appreciated his scientific input throughout all phases of this work, his elaborate advice and his guidance, which also contributed to my personal development over the last years. Furthermore, I would like to thank him for the outstanding working and team atmosphere, which he created at the chair, for supporting my participation in scientific conferences and for initiating and motivating me to the numerous collaborations which contributed to a successful thesis. -
Inhalation Devices: Various Forms of Administration for Therapeutic Optimization
vv ISSN: 2640-8082 DOI: https://dx.doi.org/10.17352/oja CLINICAL GROUP Renata Cristina de Angelo Calsaverini Leal* Review Article Santa Fé do Sul Foundation of Education and Culture, Brazil Inhalation Devices: Various forms Dates: Received: 31 May, 2017; Accepted: 26 June, of administration for Therapeutic 2017; Published: 27 June, 2017 *Corresponding author: Renata Cristina de Angelo Optimization Calsaverini Leal, Santa Fé do Sul Foundation of Education and Culture, Brazil, Tel: 55 (17) 3272-2769, E-mail: Keywords: Inhalation; Aerosol; Nebulizer Summary https://www.peertechz.com Introduction: Aerosol therapy consists of spraying liquid particles suspended for therapeutic purposes in the respiratory tract. With direct absorption and deposition at the lung level, avoiding side effects and presenting fast response time. Several factors infl uence the drug action, such as size, particle movement, ventilatory fl ow, pulmonary expansion, anatomy, respiratory mechanics and the nebulizer and patient interface. The therapeutic optimization depends on the type of nebulizer differentiating itself by the physical principle that generates the mist. Objectives: Check advantages and disadvantages of different inhalation devices. Methodology. This is a review of the PubMed database using descriptors: ultrasonic and jet nebulizer, aerosol deposition in the lung, metered dose inhaler and dry, inhaler therapy. Results: Different devices are mentioned in the literature: pneumatic and ultrasonic nebulizers (administering solutions), metered pressurized inhalers - pMDI used with or without expander chamber (administering suspensions) and dry powder inhalers - DPI (administering powder). Discussion and Conclusion: The US has advantages: quiet, does not require coordinating abilities, without propellant gases and quick nebulization with small amount of solution. Disadvantages: change in the active principle of thermosensitive drugs, deposition in the oropharynx and VAI of 2% of inhaled particles. -
Food and Drugs Regulations
LAWS OF TRINIDAD AND TOBAGO 22 Chap. 30:01 Food and Drugs SUBSIDIARY LEGISLATION FOOD AND DRUGS REGULATIONS ARRANGEMENT OF REGULATIONS REGULATION 1. Citation. 2. Requirements prescribed by regulation. 3. Interpretation. 4. Request to Director. 5. Functions, duties, responsibilities of Inspectors. 6. Certificate of appointment. 7. Taking of photographs. 8. Taking samples and detention pending further examination. 9. Violation of Act or Regulations and relabelling or recondition ing of food, drug, cosmetic or device. 10. Issue of certificate. 11. Taking a sample, notification of intention and division of sample. 12. Division an interference and objection to procedure by owner or person. 13. Certificate of Analysis. 14. Definition of terms in Part II. 15. Offence to sell unlabelled food. 16. Labelling of package. 17. Declaration of net contents not required on certain labels. 18. List of ingredients not required on certain labels. 19. Declaration not required. 20. Declaration not required to indicate presence of flavouring. 21. Dried or dehydrated products. 22. Food from vending machine. 23. Non application of regulation 16. 24. Standard for a food. 25. Name of designation given to standard, grade or definition. 26. Adulteration of food. 27. Non-adulteration. 28. Contents of package. 29. Display of information on label. 30. First Schedule. 31. Offence. 32. Definition of terms in Part III. 33. Labelling of drug. 34. Contents of label. 35. Label on bulk package. 36. Drug sold on prescription. 37. Packing cases. LAWS OF TRINIDAD AND TOBAGO Food and Drugs Chap. 30:01 23 Food and Drugs Regulations [Subsidiary} REGULATION 38. Name and proportion of drug to be stated on label. -
Inhaled Steroids in Asthma a Patient's Guide
I I v v v v d v v Patient advice and liaison service (PALS) Actions r v If you have a compliment, complaint or It is sensible to ensure you make the r concern please contact our PALS team on following steps now you have a new r 020 7288 5551 or inhaler d [email protected] d d Pick up our guide on inhalers and If you need a large print, audio or spacers to complement this leaflet translated copy of this leaflet please Inhaled Steroids in Agree on a personalised asthma contact us on 020 7288 3182. We will try plan (this is done with your doctor or our best to meet your needs. Asthma nurse and usually written down for future reference) Remember to take your medicines A patient’s guide as advised Should your inhalers fail to relieve your symptoms, go straight to Accident and Emergency Need Help? Whittington Paediatric Asthma Nurse Tel: 020 7288 5527 Whittington Health Community Nurse Magdala Avenue Islington 020 3316 1950 (8am-6pm) London N19 5NF Haringey 020 8887 3301 (9am – 5pm) Phone: 020 7272 3070 www.whittington.nhs.uk Asthma UK 0300 222 5800 Date published: 25/09/2018 www.asthma.org.uk Review date: 25/09/2020 Ref: C&YP/Paed/ISA/03 © Whittington Health Please recycle Tel: 020 7272 3070 Asthma There are many types of preventer Side Effects Asthma is a common condition affecting inhaler. There are simple steroids like Parents worry about children and young the airway. Usually a trigger (such as dust beclomethasone, and then there are also adults taking inhaled steroids because of or pollen) irritates the airways which combined inhalers, called seretide or side effects they’ve heard about. -
Member List 2016
To help make the use of prescription drugs safer and more affordable, our plan is now using a Drug Quantity Management program. That is, for certain medications, you can receive an amount to last you a certain number of days. This gives you the right amount to take the daily dose considered safe and effective, according to the recommendations of the U.S. Food and Drug Administration (FDA). Based on the FDA’s guidelines and other medical information, our plan developed this program together with Express Scripts, the company chosen to manage our prescription drug benefit. The following limits are based on a 30-day supply. If your plan allows for additional days supply, your limits may be higher. For instance, you may be able to get a 90-day supply of your medication through mail order service. Your doctor could also request a prior authorization. If this request is approved, a prior authorization would let you receive more than the recommended quantity. Drug Target Maximum Quantity ABSTRAL 100 MCG TAB SUBLINGUAL 90 units per 30 days ABSTRAL 200 MCG TAB SUBLINGUAL 90 units per 30 days ABSTRAL 300 MCG TAB SUBLINGUAL 90 units per 30 days ABSTRAL 400 MCG TAB SUBLINGUAL 90 units per 30 days ABSTRAL 600 MCG TAB SUBLINGUAL 90 units per 30 days ABSTRAL 800 MCG TAB SUBLINGUAL 90 units per 30 days ACTIQ 1,200 MCG LOZENGE 90 units per 30 days ACTIQ 1,600 MCG LOZENGE 90 units per 30 days ACTIQ 200 MCG LOZENGE 90 units per 30 days ACTIQ 400 MCG LOZENGE 90 units per 30 days ACTIQ 600 MCG LOZENGE 90 units per 30 days ACTIQ 800 MCG LOZENGE 90 units per -
Product Monograph
PRODUCT MONOGRAPH PrFLUANXOL® Flupentixol Tablets (as flupentixol dihydrochloride) 0.5 mg, 3 mg, and 5 mg PrFLUANXOL® DEPOT Flupentixol Decanoate Intramuscular Injection 2% and 10% flupentixol decanoate Antipsychotic Agent Lundbeck Canada Inc. Date of Revision: 2600 Alfred-Nobel December 12th, 2017 Suite 400 St-Laurent, QC H4S 0A9 Submission Control No : 209135 Page 1 of 35 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ..................................................................................................10 DRUG INTERACTIONS ..................................................................................................13 DOSAGE AND ADMINISTRATION ..............................................................................15 OVERDOSAGE ................................................................................................................18 ACTION AND CLINICAL PHARMACOLOGY ............................................................19 STORAGE AND STABILITY ..........................................................................................21 -
Priority for Everyone, and Even More So for Those with Chronic Illnesses
Mouth Care: Patient/Caregiver Training Hospice of Cincinnati Mouth Care is a high priority for everyone, and even more so for those with chronic illnesses. Proper mouth care has many benefits including: 1. Increasing appetite 2. Maintaining comfort 3. Clearer speech 4. Easier swallowing 5. Preventing sores and infection. General tips: Mouth care should be performed a minimum of twice daily and more frequently for dry mouth, if breathing through the mouth, or if you are not eating. Mouth care should always be performed after using an inhaler/nebulizer to prevent thrush. Thrush is slightly raised white patches or a rash typically seen on the tongue or inner cheeks. There may be pain with swallowing. Contact your hospice nurse immediately if you suspect thrush. Dentures may no longer fit well. You may consider using them only when eating or when visiting with friends and family. Questions or concerns? Call a hospice nurse at 513-891-7700. Training: Mouth Care. ©2017 Hospice of Cincinnati Hospice of Cincinnati Relieving dry mouth: 1. Increase frequency of mouth care. 2. Encourage sucking on candy, ice chips, popsicles or taking small sips of water to increase saliva. 3. Use of a mouthwash can increase dryness. Talk to your nurse about a proper mouth moisturizer/artificial saliva product. For those with difficulty swallowing: • Raise the head of the bed and support the head with pillows, turn head to one side. • Cover the upper body with a towel to keep the area clean and dry. • Remove dentures prior to mouth care and brush separately. • Use a toothette, which is a sponge-tipped oral swab, to clean the mouth and teeth using a small amount of toothpaste. -
Hydrogen Peroxide, and This Is the Same Substance That Can Be Purchased in a 32-Ounce Plastic Bottle at Walmart, for 88 Cents, Or at Walgreens for Under a $1.00
An At-Home Treatment That Can Cure Any Virus, Including Coronavirus Originally Conceptualized, circa 1990, by Charles Farr, MD Subsequently Researched and Prescribed by Frank Shallenberger, MD Current Protocol Created by Thomas Levy, MD, JD Although COVID-19, aka coronavirus, is deadly in some select cases, and it can spread rapidly, there is a simple, very inexpensive, and highly effective treatment that can treat and rapidly resolve coronavirus and virtually any other respiratory virus. While different individuals can be expected to have variable degrees of positive response, this intervention can be anticipated to eliminate eventual fatal disease outcomes in all but the most advanced cases. As I hope you will eventually experience, the treatment works for all acute viral infections, and especially well for flu viruses of any variety. In fact, although we are constantly conditioned to not believe in anything “too good to be true,” you will never have to worry about getting a cold or the flu again because you can cure it on your own. The key ingredient in this treatment is common household 3% hydrogen peroxide, and this is the same substance that can be purchased in a 32-ounce plastic bottle at Walmart, for 88 cents, or at Walgreens for under a $1.00. Perhaps you have never heard of hydrogen peroxide therapy, but since the treatment was first championed by Dr. Charles Farr in about 1990, thousands of doctors have used this therapy for decades to conquer infections in many thousands of patients throughout the world. How and Why Hydrogen Peroxide Works Because hydrogen peroxide consists of a water molecule (H2O) with an extra oxygen atom (H2O2), it is this extra oxygen atom that makes it so deadly for viruses. -
Depot Antipsychotic Injections
Mental Health Services Good Practice Statement For The Use Of DEPOT & LONG ACTING ANTIPSYCHOTIC INJECTIONS Date of Revision: February 2020 Approved by: Mental Health Prescribing Management Group Review Date: CONSULTATION The document was sent to Community Mental Health teams, Pharmacy and the Psychiatric Advisory Committee for comments prior to completion. KEY DOCUMENTS When reading this policy please consult the NHS Consent Policy when considering any aspect of consent National Institute for Clinical Excellence CG178 (2014), Psychosis and schizophrenia in adults: prevention and management NHS Lothian (2011), Depot Antipsychotic Guidance, Maudsley (2015), Prescribing Guidelines in Psychiatry 12th edition. UKPPG (2009) Guidance on the Administration to Adults of Oil based Depot and other Long Acting Intramuscular Antipsychotic Injections Summary of Product Characteristics for: Clopixol (Zuclopethixol Decanoate) Flupenthixol Decanoate Haldol (Haloperidol Decanoate) Risperdal Consta Xeplion (Paliperidone Palmitate) ZypAdhera (Olanzapine Embonate) Abilify Maintena (Aripiprazole) 1 CONTENTS REFERENCES/KEY DOCUMENTS …………………………………………………………… 1 INTRODUCTION …………………………………………………………………………………. 3 SCOPE …………………………………………………………………………………………….. 3 DEFINITIONS ……………………………………………………………………………………... 3 CHOICE OF DRUG AND DOSAGE SELECTION ……………………………………………. 3 SIDE EFFECTS ……………………………………………………………….………………….. 5 PRESCRIBING …………………………………………………………………………………… 5 ADMINISTRATION ………………………………………………………………………………. 7 RECORDING ADMINISTRATION ……………………………………………………………… 7 -
North of England Guidance for Long Acting Antipsychotic Injections July 17
Guidance on the Use of Antipsychotic Long-acting Injections in North of England (TEWV version) This guidance aims to inform and support prescribers within the three mental health service providers in the north of England in the cost-effective use of antipsychotic long-acting injections. Long-acting or “depot” injections are a useful and well-established form of administering antipsychotics in the management of schizophrenia and other psychoses. The introduction of long-acting formulations of second-generation (atypical) antipsychotics has created an additional pressure on drug budgets in mental health services, which may be justified if their use results in reduced hospital admissions, shortened length of stay and improved quality of life compared with the first generation (typical) agents. Advantages of long-acting / depot injections Assured compliance with antipsychotic treatment Increased bioavailability (less first-pass metabolism) Steady plasma levels compared to oral medication Reduction in relapse rate, severity of relapse and rehospitalisation Stable therapeutic effects Better downward titration to minimise side-effects There is some evidence that long-acting injections cause less brain tissue loss and deterioration (CATIE study1) Disadvantages of long-acting / depot injections Treatment cannot be stopped quickly if severe side-effects develop (dystonia, EPSE, NMS) Perception by the patient of “being controlled”, losing control over their treatment, or possibly being punished. Pain at the site of injection, lasting possibly 10 days Tissue necrosis - over time hard plaques may form, which will reduce the ease of administration and the efficacy of the injection as well as causing discomfort. Loss of dignity with the gluteal route Over and above these factors, NICE2 recommend that consideration should be given to offering a depot / long-acting injectable antipsychotic to people with psychosis or schizophrenia who express a preference for such treatment after an acute episode. -
Formulary Update
PEI Drug Programs Formulary Update Issue 06-04 October, 2006 The following changes and additions to the July 2006 edition of the PEI Drug Programs Formulary will be effective October 16th, 2006 unless otherwise noted within this update. If there are any questions regarding the information presented in this update please call the Drug Program office at 368-4947 or toll free at 1-877-577-3737. 1.0 Changes and Additions To The Formulary & MAC Pricing ALMOTRIPTAN (new addition) EDS Criteria: For the treatment of migraine headaches where other standard therapies, such as analgesics and/or ergotamine products have failed. Eligibility is restricted to persons over the age of 18 and under 65 years of age. Coverage is limited to 6 tablets per 30 day period. Persons requiring more than 6 doses per 30 day period should be considered for migraine prophylaxis therapy if they are not already receiving such therapy. 6.25mg tablet 02248128 AXERT (EDS) JAN FW 12.5mg tablet 02248129 AXERT (EDS) JAN FW DILTIAZEM HYDROCHLORIDE (new addition) 120mg capsule 02231150 TIAZAC BVL FNSW 180mg capsule 02231151 TIAZAC BVL FNSW 240mg capsule 02231152 TIAZAC BVL FNSW 300mg capsule 02231154 TIAZAC BVL FNSW 360mg capsule 02231155 TIAZAC BVL FNSW PEI Drug Programs Formulary Update Issue 06-04 October 2006 Page 1 DILTIAZEM HYDROCHLORIDE (new addition) 120mg extended release tablet 02256738 TIAZAC XC BVL FNSW 180mg extended release tablet 02256746 TIAZAC XC BVL FNSW 240mg extended release tablet 02256754 TIAZAC XC BVL FNSW 300mg extended release tablet 02256762 TIAZAC XC BVL FNSW 360mg extended release tablet 02256770 TIAZAC XC BVL FNSW ETHINYL ESTRADIOL/DROSPIRENONE (new addition) 3.0mg/0.03mg tablets 02261723 YASMIN 21 DAY BEX FW 02261731 YASMIN 28 DAY BEX FW ESPROSARTAN MESYLATE & HYDROCHLOROTHIAZIDE (new addition) 600mg & 12.5mg tablet 02253631 TEVETEN PLUS SLV FNSW GABAPENTIN (change) There is no longer an EDS restriction on this drug. -
Drugs That Are Not Covered
Drugs that are Not Covered* Current 10/1/21 In addition to this list, newly marketed prescription medications may not be covered until the Pharmacy & Therapeutics Committee has had an opportunity to review the medication, to determine whether the medication will be covered and if so, which tier will apply based on safety, efficacy and the availability of other products within that class of medications. The current list of newly marketed drugs can be found on our New to Market Drug list. Abilify tablets albuterol HFA inhalers (authorized Apexicon E cream Abilify MyCite tablets generics for ProAir, Proventil, Ventolin Apidra vials Absorica capsules HFA inhalers) Apidra SoloStar injection Absorica LD capsules Aldactone tablets Aplenzin tablets Abstral sublingual tablets Aldara cream Apriso capsules Acanya gel and pump gel Alkindi sprinkle capsules Arava tablets Accupril tablets Allegra Children’s Allergy ODT Arazlo lotion acetaminophen 320.5 mg/caffeine 30 Allegra ODT, suspension and tablets Arestin microspheres mg/dihydrocodeine 16 mg Alltizal tablets Aricept tablets capsulesAciphex tablets alogliptin (authorized generic for Aricept ODT Aciphex Sprinkle capsules Nesina) Arimidex tablets Acticlate tablets alogliptin/metformin tablets (authorized Arixtra injection Active-Prep kits generic for Kazano) ArmonAir Digihaler inhaler Activella tablets alogliptin/pioglitazone (authorized ArmonAir Respiclick inhaler Actonel tablets generic for Oseni) Aromasin tablets Actoplus Met tablets Alphagan P 0.1% eye drops Arthrotec 50 and 75 tablets Actos