Principals and Dosage Forms in the Therapy Modified Drug Release. Institute of Pharmaceutical Technology and Biopharmacy

Size: px
Start display at page:

Download "Principals and Dosage Forms in the Therapy Modified Drug Release. Institute of Pharmaceutical Technology and Biopharmacy"

Transcription

1 Principals and Dosage Forms in the Therapy Modified Drug Release Institute of Pharmaceutical Technology and Biopharmacy

2 Dosage forms Definition: Dosage forms are the means by which drug molecules are delivered to sites of action within the body. Dosage form API Excipients 2

3 Dosage forms Manufacturing/compounding - pharmaceutical products - Pharmaceutical products, which are suitable for direct administration are called as DOSAGE FORM. Medication (medical product) = Active pharmaceutical ingredient (API)+ excipient(s) + packaging material Packaging material Dosage form 3

4 Dosage forms They are classified according to: Route of administration 1. Oral 2. Topical 3. Rectal 4. Parenteral 5. Vaginal 6. Inhaled 7. Ophthalmic 8. Otic Physical form 1. Solid 2. Semisolid 3. Liquid 4. Gaseous 4

5 Summary Dosage forms the physico-chemical appearance of the API Liquid dosage forms Solutions drops Disperse systems containing two or more phase emulsions, suspensions Injectable products injections, infusions Semisolid dosage forms ointments, suppositories Solid dosage forms powders, dusting powders, granules, tablets, capsules

6 Solutions Solutions -as a dosage forms- are externally or internally used preparations containing active substance(s) and solvents. Solutions have to be: free from sediments, clear, liquid preparations. Homogeneous disperse system 6

7 Emulsions Emulsions - as dosage forms - are liquid preparations intended for internal or external use, containing immiscible liquid phases. One liquid phase is dispersed in the form of small droplets throughout another liquid phase. The emulsions may show evidence of phase separation but are readily redispersed on shaking.

8 SUSPENSIONS Suspensions are liquid preparations intended for internal or external use, in which the solid dispersed phase is suspended in a liquid vehicle, the solid phase is not soluble in the liquid phase (generally: distilled water). The suspended solid may slowly separate out on standing, but it is easily redispersed. d

9 SUSPENSIONS flocculated and deflocculated sediment deflocculated sediment flocculated sediment compact fitting, difficult to shake until even distribution d loose fitting, easy to shake until even distribution

10 Parenteral preparations Injections, infusions ~ are sterile preparations intended for administration by injection, infusion or implantation into the human body. Groups: Injections Infusions Concentrates for injections and infusions Powders for injections and infusions Implants Volume Isotoncity Isohydration Injections Infusions 10

11 Semi-solid preparationfor cutanaous application (Ointments) CLASSIFICATION OF SEMI-SOLID PREPARATIONFOR CUTANAOUS APPLICATION: Ointments Creams Gels Pastes Medicated plasters, patches 11

12 Preparation of ointments Machines in pharmacy

13 Rectal preparations Ph. Hg. VIII. Rectal preparations are intended for rectal use in order to obtain a systemic or local effect, or they may be intended for diagnostic purposes. Several categories of rectal preparations may be distinguished: suppositories, rectal capsules, rectal solutions, emulsions and suspensions, powders and tablets for rectal solutions and suspensions, semi-solid rectal preparations, rectal foams, rectal tampons.

14 SOLID DOSAGE FORMS Granules Small particles that can be formed by disintegration or by integration routes through which the powder forms aggregates. Granulation is the process of collecting particles together by creating bonds between them.

15 Capsules Hard gelatin capsule shells can be used at a pharmacy too. They have to be transparant.

16 Tablets Tablets are manufactured by compression. They have different shape and color.

17 Tablets Direct compression Wet or dry granulation tabletting

18 Tablets Tablet press machine(s) eccentric ~ rotary ~

19 Tablets Categories of tablets: Uncoated tablets Coated tablets Effervescent tablets Soluble tablets Dispesible tablets Orodispesible tablets Gastro-resistant tablets Modified-release tablets

20

21 LADME system liberation absorption distribution disposition metabolism excretion elimination 31/10/

22 Conventional drug release Modified drug release Rapid drug release Delayed drug release Slow drug release Pulsatile drug release Local drug release Self-regulating drug release Targeted drug release

23 Conventional drug release There is no technological modification during the manufacture to change the dissolution rate Drug release is determined by physicochemical characters

24 Factors affecting drug dissolution Physico-chemical properties of the API Polimorphism Chemical structure Particle size Complexation Wettability Impurities

25 Aspirin 500 mg tbl. Acetyl salicilyc acid Maize starch Microcrystalline cellulose

26 Modified drug release Aims: Optimizing the therapeutic effect by slowing, accelerating ordelaying the drugrelease Decrease toxic adverse effects Increase patient compliance

27 Rapid drug release Aim: Accelerating the liberation in order to reach a quick absorption

28 Nitromint 0.5 mg sublingual tablet Nitroglycerin In case of heart attack

29 Calcium 500 mg Pharmavit effervescent tablet Calcium carbonate Sodium bicarbonate Anhydrous citric acid

30 Nurofen Non-Aqua 200 mg tbl. Ibuprophen Croscarmellose sodium Lemon flavouor

31 3D printing (THERIFORM tech.) MJ Cima, JS Haggerty, EM Sachs, PA Williams. Three-dimensional printing techniques. US patent 5,204,055, Disintegrates in less than 1 s! SPRITAM 750 mg tbl.

32 THERIFORM technology

33 Delayed drug release Liberation of the API is delayed by a lag time Intestinosolvent preparations (gastric juice resistant preparations) HCl can damage the API API can damage the gastric mucosa

34 Delayed drug release 34

35 Pharmaceutical Excipients used to create delayed release preparations ph sensitive coating Intestinosolvent/gastroresistant coating Celluloseacetate phtalate (CAP) Eudragit L,S (metactylic acid copolimers)

36 Pancreas powder Kreon cps.

37 Diffucaps - delayed release Chronotherapeutic system (2003)

38 Diffucaps - delayed release Chronotherapeutic system (2003)

39 Slow/sustained drug release Release of API is slow, thus the step of the liberation is determinant for the absorption It is reasonable at APIs with short half-life and to avoid plasm fluctuations

40 Slow/sustained release Special case Drug dissolution at constant rate, Zero Order Kinetics (ZOK)

41 Pharmaceutical Excipients to create slow/sustainedrelease preparations Biodegradable and/or coated preparations Eudragit RL, RS, NE (metacrylesther copolimers)

42 Kaldyum Potassium-chloride 30%-os polyacrylate aqeousdispersion

43 Slow/sustained release Multiple unit pellet system (MUPS)

44 MUPS (1991)

45 Slow/sustained release Matrix systems ph sensitive Biodegradable. Hidrophilic(alginic acid and derivatives) Hidrophobic(ethyl-cellulose)

46 Slow/sustainedrelease preparations Osmotic systems (OROS): Water-soluble APIs: Elementary Osmotic Pump (EOP) Water-insoluble /less soluble APIs: Gastrointestinal Therapeutic System (GITS)

47 Osmotic technologies ALZA Corp Dr. Alejandro Zaffaroni

48 Gastrointestinal Therapeutic System

49 Gastrointestinal Therapeutic System

50 Glargin analog insulin (Lantus SoloStar )

51 Glargin analog insulin

52 Pulsatile drug release Drug release shows a pulsatile pattern Reaseonable at circadiandiseases

53 Pulsatile drug release

54 Pulsatile drug release c p c pmax n=1 n=2 n=3 n=4 n=5 n=6 n=7 adás t

55 Local drug release Reasonable: If the API absorbs from a definite section of the GI tract Stability is adequate at low ph Colon-specific drug delivery

56 Local drug release (Gastroretentive tablets)

57 Targeted drug release Significant at cancer diseases API Injected to the target organ Transferred to the blood vessel of the cancerous tissue Targeting is realised by magnetic field Sonic waves, ultrasound, heat trigger the drug release Appliedby targeting molecule

58 Visudyne - liposome containing targeted drug release

59 Thank you for your attention! 59

Principals and dosage forms of pharmaceutics

Principals and dosage forms of pharmaceutics Principals and dosage forms of pharmaceutics Part II. Semisolid dosage forms: ointments, creams, gels, pastes, suppositories, pessaries 2017 Dr. Farkas, Gyula Pharmaceutical Propedeutics Institute of Pharmaceutical

More information

PHARMACEUTICS I صيدالنيات 1 UNIT 1 INTRODUCTION

PHARMACEUTICS I صيدالنيات 1 UNIT 1 INTRODUCTION PHARMACEUTICS I صيدالنيات 1 UNIT 1 INTRODUCTION 1 PHARMACEUTICS Pharmaceutics is the science of dosage form design. The general area of study concerned with the formulation, manufacture, stability, and

More information

Biopharmaceutics Dosage form factors influencing bioavailability Lec:5

Biopharmaceutics Dosage form factors influencing bioavailability Lec:5 Biopharmaceutics Dosage form factors influencing bioavailability Lec:5 Ali Y Ali BSc Pharmacy MSc Industrial Pharmaceutical Sciences Dept. of Pharmaceutics School of Pharmacy University of Sulaimani 09/01/2019

More information

Pharmaceutical Preparation For Internal Use

Pharmaceutical Preparation For Internal Use Pharmaceutical Preparation For Internal Use 1. Solid Preparations (Tablet, Capsule, Pill) 2. Liquid Preparations (Aqua, Syrup, Elixir, Extract, Liquor, Emulsion, Mixture, Infusion, Decoction). 3. Powder

More information

Tablet is a major category of solid dosage forms which are widely used worldwide. Extensive information is required to prepare tablets with good

Tablet is a major category of solid dosage forms which are widely used worldwide. Extensive information is required to prepare tablets with good TABLET PRODUCTİON Tablet is a major category of solid dosage forms which are widely used worldwide. Extensive information is required to prepare tablets with good quality at high standards. Based on preformulation

More information

UNIT 2 SOLID AND LIQUID DOSAGE FORMS

UNIT 2 SOLID AND LIQUID DOSAGE FORMS UNIT 2 SOLID AND LIQUID DOSAGE FORMS Solid and Liquid Structure 2.1 Introduction Objectives 2.2 Solid Tablets Capsules 2.3 Liquid Advantages of Liquid Disadvantages of Liquid Classification of Liquid Monophasic

More information

Assessment of Human Pharmaceutical Products Registered in Kenya by Route of Administration and Type of Dosage Form

Assessment of Human Pharmaceutical Products Registered in Kenya by Route of Administration and Type of Dosage Form 38 East and Central African Journal of Pharmaceutical Sciences Vol. 15 (2012) 38-46 Assessment of Human Pharmaceutical Products Registered in Kenya by Route of Administration and Type of Dosage Form N.N.

More information

Routes of drug administration

Routes of drug administration Routes of drug administration Definition:- A route of administration in pharmacy is the path by which a drug is taken into the body. Classification:- The various routes of administrations are classified

More information

LAB.2. Tablet Production Methods

LAB.2. Tablet Production Methods LAB.2 Tablet Production Methods Dry methods Direct compression Dry granulation Wet methods Wet granulation Regardless whether tablets are made by direct compression or granulation, the first step, milling

More information

<1151> Pharmaceutical Dosage Forms and <1152> Animal Drugs for Use in Animal Feeds

<1151> Pharmaceutical Dosage Forms and <1152> Animal Drugs for Use in Animal Feeds Pharmaceutical Dosage Forms and Animal Drugs for Use in Animal Feeds Will Brown Veterinary Drugs Stakeholder Forum February 19-20, 2014 Development of a Compendial Taxonomy and Glossary for

More information

T Pharmaceutics-I (Dispensing Pharmacy)

T Pharmaceutics-I (Dispensing Pharmacy) T.1.1.1. Pharmaceutics-I (Dispensing Pharmacy) Dosage Forms 1. Define Dosage Forms. Give classification. 2. Define: Creams, Pastes, Gargles, Elixirs, 3. Give Classification of dosage form. Prescription

More information

INFORMATION TOPIC: II-5 OR DEMONSTRATION: II-5. DOSAGE, MEASUREMENTS, AND DRUG FORMS (Lesson Title) OBJECTIVES THE STUDENT WILL BE ABLE TO:

INFORMATION TOPIC: II-5 OR DEMONSTRATION: II-5. DOSAGE, MEASUREMENTS, AND DRUG FORMS (Lesson Title) OBJECTIVES THE STUDENT WILL BE ABLE TO: LESSON PLAN: 5 COURSE TITLE: UNIT: II MEDICATION TECHNICIAN GENERAL PRINCIPLES SCOPE OF UNIT: This unit includes medication terminology, dosage, measurements, drug forms, transcribing physician s orders,

More information

Large scale production

Large scale production Large scale production Rotary capsule machine: This machine has two, side-by-side cylinders in each of which half-moulds are cut. These cylinders, like the rollers of a mangle, rotate in contrary direction

More information

PHAR 7632 Chapter 7. Table Market and Share of Pharmaceuticals by ROA Data from Viswanathan, 2004

PHAR 7632 Chapter 7. Table Market and Share of Pharmaceuticals by ROA Data from Viswanathan, 2004 Student Objectives for this Chapter After completing the material in this chapter each student should:- be able to describe various routes of drug administration including the concentration versus time

More information

REVISION OF MONOGRAPH ON TABLETS. Tablets

REVISION OF MONOGRAPH ON TABLETS. Tablets March 2011 REVISION OF MONOGRAPH ON TABLETS Final text for addition to The International Pharmacopoeia This monograph was adopted by the Forty-fourth WHO Expert Committee on Specifications for Pharmaceutical

More information

CHAPTER-I DRUG CHARACTERIZATION & DOSAGE FORMS

CHAPTER-I DRUG CHARACTERIZATION & DOSAGE FORMS CHAPTER-I DRUG CHARACTERIZATION & DOSAGE FORMS by: j. jayasutha lecturer department of pharmacy practice Srm college of pharmacy srm university DRUG CHARACTERIZATION: Pre-formulation studies will attempt

More information

KING KHALID UNIVERSITY

KING KHALID UNIVERSITY KING KHALID UNIVERSITY COLLEGE OF PHARMACY DEPARTMENT OF PHARMACEUTICS COURSE SCHEDULE MALE SECTION SOLID DOSAGE FORMS FOR PHARMACEUTICAL SCIENCES/CLINICAL PHARMACY BY PROF DR MOHAMED FATHY Academic Session

More information

Formulation and Evaluation

Formulation and Evaluation Chapter-5 Formulation and Evaluation 5.1 OBJECTIVE After successful taste masking and solubility enhancement of drugs in preliminary studies, by using Mannitol Solid Dispersion, next step includes the

More information

INFORMATION TOPIC: II-5 OR DEMONSTRATION: II-5. DOSAGE, MEASUREMENTS, AND DRUG FORMS (Lesson Title) OBJECTIVES THE STUDENT WILL BE ABLE TO:

INFORMATION TOPIC: II-5 OR DEMONSTRATION: II-5. DOSAGE, MEASUREMENTS, AND DRUG FORMS (Lesson Title) OBJECTIVES THE STUDENT WILL BE ABLE TO: LESSON PLAN: 5 COURSE TITLE: UNIT: II MEDICATION TECHNICIAN GENERAL PRINCIPLES SCOPE OF UNIT: This unit includes medication terminology, dosage, measurements, drug forms, transcribing physician s orders,

More information

CONTROLLED-RELEASE & SUSTAINED-RELEASE DOSAGE FORMS. Pharmaceutical Manufacturing-4

CONTROLLED-RELEASE & SUSTAINED-RELEASE DOSAGE FORMS. Pharmaceutical Manufacturing-4 CONTROLLED-RELEASE & SUSTAINED-RELEASE DOSAGE FORMS Pharmaceutical Manufacturing-4 The improvement in drug therapy is a consequence of not only the development of new chemical entities but also the combination

More information

SUMMARY AND CONCLUSION

SUMMARY AND CONCLUSION SUMMARY AND CONCLUSION 8 SUMMARY AND CONCLUSIONS In spite of the many challenges faced by researchers while designing an effective, reproducible and stable dosage form, oral dosage forms continued to maintain

More information

STARCH Proven and Trusted Excipient for Performance and Versatility EXCIPIENTS. Effective and economical disintegrant

STARCH Proven and Trusted Excipient for Performance and Versatility EXCIPIENTS. Effective and economical disintegrant EXCIPIENTS STARCH 1500 Proven and Trusted Excipient for Performance and Versatility Effective and economical disintegrant Excellent stability for moisture sensitive drugs Manufactured exclusively for the

More information

Introduction to. Pharmacokinetics. University of Hawai i Hilo Pre-Nursing Program NURS 203 General Pharmacology Danita Narciso Pharm D

Introduction to. Pharmacokinetics. University of Hawai i Hilo Pre-Nursing Program NURS 203 General Pharmacology Danita Narciso Pharm D Introduction to 1 Pharmacokinetics University of Hawai i Hilo Pre-Nursing Program NURS 203 General Pharmacology Danita Narciso Pharm D 2 Learning objectives Understand compartment models and how they effects

More information

1. Gastric Emptying Time Anatomically, a swallowed drug rapidly reaches the stomach. Eventually, the stomach empties its content in the small

1. Gastric Emptying Time Anatomically, a swallowed drug rapidly reaches the stomach. Eventually, the stomach empties its content in the small Lecture-5 1. Gastric Emptying Time Anatomically, a swallowed drug rapidly reaches the stomach. Eventually, the stomach empties its content in the small intestine. Because the duodenum has the greatest

More information

Pharmaceutics I صيدالنيات 1. Unit 2 Route of Drug Administration

Pharmaceutics I صيدالنيات 1. Unit 2 Route of Drug Administration Pharmaceutics I صيدالنيات 1 Unit 2 Route of Drug Administration 1 Routs of Drug administration The possible routes of drug entry into the body may be divided into two classes: Parenteral Rout Enteral Rout

More information

Chapter 7. Principles of Pharmacology

Chapter 7. Principles of Pharmacology Chapter 7 Principles of Pharmacology Introduction Administering medications is a serious business. Medications may alleviate pain and improve patient s well-being. Used inappropriately, may cause harm

More information

Long-Term Care Updates

Long-Term Care Updates Long-Term Care Updates May 2016 By Katee Miller, PharmD Candidate, Mohamed Jalloh, PharmD, & Zara Risoldi Cochrane, PharmD, MS, FASCP Introduction Enteral nutrition (EN) through a tube is the preferred

More information

6. SR, XR, CR, and TR are examples of formulations. A) oral B) modified release C) repeat action D) soft gels

6. SR, XR, CR, and TR are examples of formulations. A) oral B) modified release C) repeat action D) soft gels 1. Which is a parenteral route of administration? A) oral B) vaginal C) sublingual D) rectal 2. A local effect occurs A) at the site of administration. B) throughout the body. C) only after intravenous

More information

Development of Nutrient Delivery Systems: Ingredients & Challenges

Development of Nutrient Delivery Systems: Ingredients & Challenges Development of Nutrient Delivery Systems David Julian McClements and Hang Xiao Department of Food Science University of Massachusetts Development of Nutrient Delivery Systems: Ingredients & Challenges

More information

PHARMACEUTICAL AID PREPARED BY B.KIRUTHIGA LECTURER DEPT OF PHARMACEUTICAL CHEMISTRY

PHARMACEUTICAL AID PREPARED BY B.KIRUTHIGA LECTURER DEPT OF PHARMACEUTICAL CHEMISTRY PHARMACEUTICAL AID PREPARED BY B.KIRUTHIGA LECTURER DEPT OF PHARMACEUTICAL CHEMISTRY Excipients are inactive ingredients used as carriers for the active ingredients in a pharmaceutical product. These may

More information

NANO 243/CENG 207 Course Use Only

NANO 243/CENG 207 Course Use Only L6. Drug Administration & Transport by Fluid Motion April 19, 2018 Part I: Drug Administration Routes of Drug Administration Topical: local effect, substance is applied directly where its action is desired.

More information

7. SUMMARY, CONCLUSION AND RECOMMENDATIONS

7. SUMMARY, CONCLUSION AND RECOMMENDATIONS 211 7. SUMMARY, CONCLUSION AND RECOMMENDATIONS Drug absorption from the gastro intestinal tract can be limited by various factors with the most common one being poor aqueous solubility and poor permeability

More information

ph Dependent Drug Delivery System: Review

ph Dependent Drug Delivery System: Review ph Dependent Drug Delivery System: Review Korake.S.P. SVERI s College of Pharmacy (Poly.), Pandharpur The ph-dependent CTDDS exploit the generally accepted view that ph of the human GIT increases progressively

More information

Is the science that study relation of physicochemical properties of drug, dosage form, & route of administration on rate and extent of drug

Is the science that study relation of physicochemical properties of drug, dosage form, & route of administration on rate and extent of drug Chapter 5 Is the science that study relation of physicochemical properties of drug, dosage form, & route of administration on rate and extent of drug absorption. It is the study of the kinetics of absorption,

More information

Industrial Pharmacy (3) Solutions as a dosage form. DR.Saad.M.YACOUB

Industrial Pharmacy (3) Solutions as a dosage form. DR.Saad.M.YACOUB Industrial Pharmacy (3) Solutions as a dosage form DR.Saad.M.YACOUB Solutions: definition A solution is a homogenous one-phase system consisting of two or more components. The solvent, or mixture of solvents,

More information

Brand and Generic Drugs. Educational Objectives. Absorption

Brand and Generic Drugs. Educational Objectives. Absorption Peter J. Rice, PharmD, PhD Associate Professor of Pharmacology East Tennessee State University Educational Objectives Pharmacokinetic Processes Distribution Metabolism Excretion Similarities Active ingredient(s)

More information

LIQUID PREPARATIONS FOR ORAL USE. Final text for addition to The International Pharmacopoeia (November 2007)

LIQUID PREPARATIONS FOR ORAL USE. Final text for addition to The International Pharmacopoeia (November 2007) November 2007 LIQUID PREPARATIONS FOR ORAL USE Final text for addition to The International Pharmacopoeia (November 2007) This monograph was adopted at the Forty-second WHO Expert Committee on Specifications

More information

Fundamentals of Pharmacology for Veterinary Technicians Chapter 4

Fundamentals of Pharmacology for Veterinary Technicians Chapter 4 (A) (B) Figure 4-1 A, B (C) FIGURE 4-1C The active transport process moves particles against the concentration gradient from a region of low concentration to a region of high concentration. Active transport

More information

Controlled Delivery of Biologics NBC 22 June 2009

Controlled Delivery of Biologics NBC 22 June 2009 Controlled Delivery of Biologics NBC 22 June 2009 ivery System Overview, Chris Rhodes, Amylin ulatory Perspectives, Mei-Ling Chen,FDA tained Circulation Strategies, Tim Riley, Nektar nsdermal Microporation,

More information

University of Sulaimani School of Pharmacy Dept. of Pharmaceutics Third level - Second semester

University of Sulaimani School of Pharmacy Dept. of Pharmaceutics Third level - Second semester University of Sulaimani School of Pharmacy Dept. of Pharmaceutics Third level - Second semester 5/21/2017 Pharmaceutical Compounding, Dr. rer. nat. Rebaz Ali 1 Outlines Why rectal or vaginal route? Suppository

More information

Interactions and incompatibilities in pharmaceutical preparations. University of Pécs Institute of Pharmaceutical Technology and Biopharmacy

Interactions and incompatibilities in pharmaceutical preparations. University of Pécs Institute of Pharmaceutical Technology and Biopharmacy Interactions and incompatibilities in pharmaceutical preparations University of Pécs Institute of Pharmaceutical Technology and Biopharmacy Medicinal interactions Processes which influence the medicines:

More information

Compounding Options in Women s Health: Dosage Forms

Compounding Options in Women s Health: Dosage Forms Compounding Options in Women s Health: Dosage Forms Ranel A. Larsen, RPh, PharmD HRT Symposium Las Vegas, NV February 16 18, 2017 Routes of Administration Common: Topical Oral Sublingual Vaginal Other:

More information

EXPANDING WHAT S POSSIBLE WITH THE RIGHT PARTNER. Life-saving pharmaceuticals start with high-quality ingredients

EXPANDING WHAT S POSSIBLE WITH THE RIGHT PARTNER. Life-saving pharmaceuticals start with high-quality ingredients EXPANDING WHAT S POSSIBLE WITH THE RIGHT PARTNER Life-saving pharmaceuticals start with high-quality ingredients CONFIDENCE STRAIGHT FROM THE SOURCE From oral dosage excipients (Rx, Gx, nutraceuticals

More information

LIST OF TABLES. Page No. No List of US Patents for FDDS Gastroretentive products available in the market

LIST OF TABLES. Page No. No List of US Patents for FDDS Gastroretentive products available in the market LIST OF TABLES Sl. Table Title of the table 1 3.01 List of US Patents for FDDS 27 2 3.02 List of drugs explored for various floating dosage forms 35 3 3.03 Gastroretentive products available in the market

More information

TYPES OF DOSAGE FORMS

TYPES OF DOSAGE FORMS TYPES OF DOSAGE FORMS Types of dosage forms: Definition: Dosage forms are the means by which drug molecules are delivered to sites of action within the body. The need for dosage forms: 1- Accurate dose.

More information

Parenteral Products. By: Howida Kamal, Ph.D

Parenteral Products. By: Howida Kamal, Ph.D Parenteral Products By: Howida Kamal, Ph.D Dosage forms Route of administration Enteral INTO Parenteral ONTO Topical Dosage forms Physical form Solid Liquid Semi-solid Powder Granules Tablets Capsules

More information

Different Type of Dosage Form. Pharmaceutics I

Different Type of Dosage Form. Pharmaceutics I Different Type of Dosage Form 1 Pharmaceutics I Types of dosage forms: Definition: Dosage forms are the means by which drug molecules are delivered to sites of action within the body. The need for dosage

More information

11:00-11:50 AM 8:00-8:50 AM

11:00-11:50 AM 8:00-8:50 AM 5117 5115 5219 5111 5113 5117 5115 5219 5111 5117 5115 5219 5113 5115/5219 5111 5121 01/08 #1 9- MAKE UP 5111 or OR PM See PM See 5113 CH2 S. SCRIPTS 10:00 1- Schedule Schedule Salk 456 or Biosignaling

More information

AMENDMENTS TO THE SECOND REVISION OF THE FIRST EDITION OF THE MANUAL ON DEVELOPMENT AND USE OF FAO AND WHO SPECIFICATIONS FOR PESTICIDES

AMENDMENTS TO THE SECOND REVISION OF THE FIRST EDITION OF THE MANUAL ON DEVELOPMENT AND USE OF FAO AND WHO SPECIFICATIONS FOR PESTICIDES AMENDMENTS TO THE SECOND REVISION OF THE FIRST EDITION OF THE MANUAL ON DEVELOPMENT AND USE OF FAO AND WHO SPECIFICATIONS FOR PESTICIDES Page Current text Revised text Notes P.21 A. 10.1. WHO classification

More information

Determination of bioavailability

Determination of bioavailability Pharmaceutics 2 Bioavailability Bioavailability is the rate and extent to which an administered drug reaches the systemic circulation. For example, if 100 mg of a drug is administered orally and 70 mg

More information

Easy, fast and reliable!

Easy, fast and reliable! Product Overview Easy, fast and reliable! Special easy-to-use preparations for film coating, sugar-coating, colouring and tabletting. Tailormade formulated. s film coating products are one-step coating

More information

Easy, fast and reliable!

Easy, fast and reliable! Product Overview Easy, fast and reliable! Special easy-to-use preparations for film coating, sugar-coating, colouring and tabletting. s film coating products are one-step coating systems for pharmaceutical

More information

905 UNIFORMITY OF DOSAGE UNITS

905 UNIFORMITY OF DOSAGE UNITS Change to read: 905 UNIFORMITY OF DOSAGE UNITS [ NOTE In this chapter, unit and dosage unit are synonymous. ] To ensure the consistency of dosage units, each unit in a batch should have a drug substance

More information

SOFT GELATIN CAPSULE. Dr. Nawal Ayash

SOFT GELATIN CAPSULE. Dr. Nawal Ayash SOFT GELATIN CAPSULE Dr. Nawal Ayash 1 Soft gelatin capsule DEFINITION:- soft Gelatin capsules are one piece, hermetically sealed, soft gelatin shells containing a liquid, a suspension, or a semisolid.

More information

FORMULATION AND EVALUATION OF PIROXICAM AND CELECOXIB TABLETS EMPLOYING PROSOLVE BY DIRECT COMPRESSION METHOD

FORMULATION AND EVALUATION OF PIROXICAM AND CELECOXIB TABLETS EMPLOYING PROSOLVE BY DIRECT COMPRESSION METHOD Int. J. Chem. Sci.: 6(3), 2008, 1270-1275 FORMULATION AND EVALUATION OF PIROXICAM AND CELECOXIB TABLETS EMPLOYING PROSOLVE BY DIRECT COMPRESSION METHOD K. P. R. CHOWDARY, P. TRIPURA SUNDARI and K. SURYA

More information

Achieving Optimal Particle Size Distribution in Inhalation Therapy

Achieving Optimal Particle Size Distribution in Inhalation Therapy Achieving Optimal Particle Size Distribution in Inhalation Therapy By Bob Bruno Inhalation therapy has proven to be an effective method of administering a number of pharmaceuticals for more than a century.

More information

EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL VOLUME 2C. Guidelines. Medicinal products for human use

EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL VOLUME 2C. Guidelines. Medicinal products for human use EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL Brussels, March 2018 SANTE-2017-11668 Revision 2 NOTICE TO APPLICANTS VOLUME 2C Guidelines Medicinal products for human use Safety, environment

More information

FORMULATION DEVELOPMENT - A QbD Approach to Develop Extended Release Softgels

FORMULATION DEVELOPMENT - A QbD Approach to Develop Extended Release Softgels Seite 1 von 8 Share this story: Issue: April 2015, Posted Date: 3/30/2015 FORMULATION DEVELOPMENT - A QbD Approach to Develop Extended Release Softgels INTRODUCTION Soft gelatin capsules (softgels) continue

More information

Drug Development by Government Pharmaceutical Organization. Dr. Rachaneekorn Jevprasesphant The Government Pharmaceutical Organization (GPO) Thailand

Drug Development by Government Pharmaceutical Organization. Dr. Rachaneekorn Jevprasesphant The Government Pharmaceutical Organization (GPO) Thailand Drug Development by Government Pharmaceutical Organization Dr. Rachaneekorn Jevprasesphant The Government Pharmaceutical Organization (GPO) Thailand 20August 2012 GPO s Profile GPO was established in 1966.

More information

Direct Compression. With the right ingredients it s a simple, cost-effective manufacturing process

Direct Compression. With the right ingredients it s a simple, cost-effective manufacturing process Direct With the right ingredients it s a simple, cost-effective manufacturing process TM Trademark of The Dow Chemical Company ( Dow ) or an affiliated company of Dow Speed and savings sounds good to us

More information

Emulsions. Purpose of emulsions and of emulsification:

Emulsions. Purpose of emulsions and of emulsification: Pharmacist Ghada Hamid Emulsions Emulsion is a dispersion in which the dispersed phase is composed of small globules of a liquid distributed throughout a vehicle in which it is immiscible. The dispersed

More information

Formulation and Evaluation of Gastroretentive Dosage form of Ciprofloxacin Hydrochloride.

Formulation and Evaluation of Gastroretentive Dosage form of Ciprofloxacin Hydrochloride. Available online on www.ijcpr.com International Journal of Current Pharmaceutical Review and Research, 3(4), 105-109 Research Article ISSN: 0976-822X Formulation and Evaluation of Gastroretentive Dosage

More information

CONTENTS PAGE. Please note: Preface Matrix system Selection of METOLOSE grades Specifications

CONTENTS PAGE. Please note: Preface Matrix system Selection of METOLOSE grades Specifications Hypromellose CONTENTS PAGE 2 Preface Matrix system Selection of METOLOSE grades Specifications Properties Powder Solution Application Related Patents 3 4-5 6 8 10 13 14 17 Please note: The information

More information

INTERNATIONAL PHARMACOPOEIA MONOGRAPH ON LIQUID PREPARATIONS FOR ORAL USE

INTERNATIONAL PHARMACOPOEIA MONOGRAPH ON LIQUID PREPARATIONS FOR ORAL USE RESTRICTED INTERNATIONAL PHARMACOPOEIA MONOGRAPH ON LIQUID PREPARATIONS FOR ORAL USE REVISED DRAFT FOR DISCUSSION World Health Organization 2007 All rights reserved. This draft is intended for a restricted

More information

Innovations in Design: NIA-West. Missy Lowery, MSc Head of Integrated Marketing Capsugel, now a Lonza company 11/13/2017

Innovations in Design: NIA-West. Missy Lowery, MSc Head of Integrated Marketing Capsugel, now a Lonza company 11/13/2017 Innovations in Design: NIA-West Missy Lowery, MSc Head of Integrated Marketing Capsugel, now a Lonza company 11/13/2017 1 Innovations in Design: How Do You Stand Out? If all other competitors are the same

More information

DISCIPLINE RECORD/ COURSE / SEMINAR DESCRIPTION

DISCIPLINE RECORD/ COURSE / SEMINAR DESCRIPTION Universitatea de Medicină şi Farmacie Grigore T. Popa Iaşi Comisia pentru asigurarea calităţii DISCIPLINE RECORD/ COURSE / SEMINAR DESCRIPTION 1. Information about the program UNIVERSITY: GRIGORE T. POPA

More information

The unlocked synergy of DFE Pharma MCC

The unlocked synergy of DFE Pharma MCC The unlocked synergy of DFE Pharma MCC We are DFE Pharma We are the global leader in excipient solutions. We develop, produce and market excipients for oral solid dose and dry powder inhalation formulations.

More information

Formulation and evaluation of sublingual tablets of lisinopril

Formulation and evaluation of sublingual tablets of lisinopril Journal of GROVER Scientific & Industrial AGARWAL: Research FORMULATION AND EVALUATION OF SUBLINGUAL TABLETS OF LISINOPRIL Vol. 71, June 2012, pp. 413-417 413 Formulation and evaluation of sublingual tablets

More information

GUIDELINE ON THE CATEGORISATION OF EXTENSION APPLICATIONS (EA) versus VARIATIONS APPLICATIONS (V) OCTOBER 2003

GUIDELINE ON THE CATEGORISATION OF EXTENSION APPLICATIONS (EA) versus VARIATIONS APPLICATIONS (V) OCTOBER 2003 EUROPN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market, implementation and legislation for consumer goods Pharmaceuticals : regulary framework and market authorisations Brussels, F2/AW D(2002)

More information

A Comparative Evaluation of Cross Linked Starch Urea-A New Polymer and Other Known Polymers for Controlled Release of Diclofenac

A Comparative Evaluation of Cross Linked Starch Urea-A New Polymer and Other Known Polymers for Controlled Release of Diclofenac Asian Journal of Chemistry Vol. 22, No. 6 (2010), 4239-4244 A Comparative Evaluation of Cross Linked Starch Urea-A New Polymer and Other Known Polymers for Controlled Release of Diclofenac K.P.R. CHOWDARY*

More information

Solid and sterile finished dosage forms. Delivered.

Solid and sterile finished dosage forms. Delivered. Solid and sterile finished dosage forms. Delivered. This is where your discoveries take form. Oral Solids Access a remarkable range of conventional and specialized oral solid dosage form capabilities and

More information

ORAL DOSAGE OVERVIEW

ORAL DOSAGE OVERVIEW ORAL DOSAGE OVERVIEW AN UNWAVERING COMMITMENT TO ENABLING LIFE-SAVING PHARMACEUTICALS The safety of your patients is your number one priority. That s why the quality and stability of your formulations

More information

DEVELOPMENT AND IN VITRO EVALUATION OF SUSTAINED RELEASE FLOATING MATRIX TABLETS OF METFORMIN HYDROCHLORIDE

DEVELOPMENT AND IN VITRO EVALUATION OF SUSTAINED RELEASE FLOATING MATRIX TABLETS OF METFORMIN HYDROCHLORIDE ISSN: 0975-8232 IJPSR (2010), Vol. 1, Issue 8 (Research article) Received 11 April, 2010; received in revised form 17 June, 2010; accepted 13 July, 2010 DEVELOPMENT AND IN VITRO EVALUATION OF SUSTAINED

More information

DRY SYRUPS SWAPNA.M. Ist semester DEPARTMENT OF PHARMACEUTICS UNIVERSITY COLLEGE OF PHARMACEUTICAL SCIENCES KAKATIYA UNIVERSITY, WARANGAL SEMINAR BY

DRY SYRUPS SWAPNA.M. Ist semester DEPARTMENT OF PHARMACEUTICS UNIVERSITY COLLEGE OF PHARMACEUTICAL SCIENCES KAKATIYA UNIVERSITY, WARANGAL SEMINAR BY DRY SYRUPS SEMINAR BY SWAPNA.M M.PHARMACY Ist semester DEPARTMENT OF PHARMACEUTICS UNIVERSITY COLLEGE OF PHARMACEUTICAL SCIENCES KAKATIYA UNIVERSITY, WARANGAL CONTENTS DEFINITION CHARACTERISTICS OF SUSPENSIONS

More information

Suppository Chapter Content

Suppository Chapter Content 10 min SUPPOSITORY Suppository Chapter Content 1. Suppositories and Factors Affecting Drug Absorption 2. Ideal Suppository and Different Types of Bases 3. Methods of Suppository Manufacturing Suppository

More information

Revised European Guideline on PK and Clinical Evaluation of Modified Release Dosage Forms

Revised European Guideline on PK and Clinical Evaluation of Modified Release Dosage Forms 1st MENA Regulatory Conference on Bioequivalence, Biowaivers, Bioanalysis and Dissolution Jordan September 23 24, 2013 Revised European Guideline on PK and Clinical Evaluation of Modified Release Dosage

More information

EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL VOLUME 2C. Guidelines. Medicinal products for human use

EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL VOLUME 2C. Guidelines. Medicinal products for human use EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL Brussels, Draft Revision 2 NOTICE TO APPLICANTS VOLUME 2C Guidelines Medicinal products for human use Safety, environment and information

More information

SCIENTIFIC DISCUSSION. Efavirenz

SCIENTIFIC DISCUSSION. Efavirenz SCIENTIFIC DISCUSSION Name of the Finished Pharmaceutical Product: Manufacturer of Prequalified Product: Active Pharmaceutical Ingredient (API): Pharmaco-therapeutic group (ATC Code): Therapeutic indication:

More information

Non-Food Uses of Polysaccharides

Non-Food Uses of Polysaccharides Non-Food Uses of Polysaccharides John Mitchell John.Mitchell@biopolymersolutions.co.uk Acknowledgements Fundamentals of Hydrocolloid Technology Course (2003-2009) Rob Winwood Colin Melia Steve Harding

More information

FORMULATION CHOICE. How and why they are chosen. Dr Andy Fowles On behalf of ECPA Specification Expert Group

FORMULATION CHOICE. How and why they are chosen. Dr Andy Fowles On behalf of ECPA Specification Expert Group FORMULATION CHOICE How and why they are chosen Dr Andy Fowles On behalf of ECPA Specification Expert Group Topics Why formulate? How to identify formulation options Drivers Principle formulation type overview

More information

Biswajit Biswal IRJP 2 (7)

Biswajit Biswal IRJP 2 (7) INTERNATIONAL RESEARCH JOURNAL OF PHARMACY ISSN 2230 8407 Available online http://www.irjponline.com Research Article DESIGN DEVELOPMENT AND EVALUATION OF TRIMETAZIDINE DIHYDROCHLORIDE FLOATING BILAYER

More information

Available Online through Research Article

Available Online through Research Article ISSN: 0975-766X Available Online through Research Article www.ijptonline.com DESIGN AND EVALUATION OF GASTRORETENTIVE TABLETS FOR CONTROLLED DELIVERY OF NORFLOXOCIN Ganesh Kumar Gudas*, Subal Debnath,

More information

FLORITER. New Technology for Innovative Formulation Design.

FLORITER. New Technology for Innovative Formulation Design. FLORITER New Technology for Innovative Formulation Design www.tomitaph.co.jp FLORITE Dramatically Change Your Formulation FLORITE is synthetic Calcium Silicate with exceptional liquid absorbency and excellent

More information

CHAPTER 5: FORMULATION OF SOLID DOSAGE FORM (TABLET & CAPSULES) INTRODUCTION

CHAPTER 5: FORMULATION OF SOLID DOSAGE FORM (TABLET & CAPSULES) INTRODUCTION CHAPTER 5: FORMULATION OF SOLID DOSAGE FORM (TABLET & CAPSULES) INTRODUCTION LEARNING OBJECTIVES The objectives of this unit are to: Understand the formulation of solid dosage form. Understand the characteristic

More information

PARENTERAL PREPARATIONS

PARENTERAL PREPARATIONS PARENTERAL PREPARATIONS INTRODUCTION Parenteral (Gk, para enteron, beside the intestine) dosage forms differ from all other drug dosage forms, because they are injected directly into body tissue through

More information

International Journal of Innovative Pharmaceutical Sciences and Research

International Journal of Innovative Pharmaceutical Sciences and Research International Journal of Innovative Pharmaceutical Sciences and Research www.ijipsr.com FORMULATION AND EVALUATION OF MODIFIED REALEASE CAPSULES OF BUDESONIDE 1 K.Veera Kumari*, 2 Dr. Appa Rao, 3 Dr.Shaik.Harun

More information

Physical Pharmacy. Interfacial phenomena. Khalid T Maaroof MSc. Pharmaceutical sciences School of pharmacy Pharmaceutics department

Physical Pharmacy. Interfacial phenomena. Khalid T Maaroof MSc. Pharmaceutical sciences School of pharmacy Pharmaceutics department Physical Pharmacy Interfacial phenomena Khalid T Maaroof MSc. Pharmaceutical sciences School of pharmacy Pharmaceutics department 1 Introduction The boundary between two phases is generally described as

More information

Laboratory Pesticide Formulations, Labels, and Safety

Laboratory Pesticide Formulations, Labels, and Safety 1 Laboratory Pesticide Formulations, Labels, and Safety I. Pesticide Formulations Pesticides are rarely used in their pure form (technical grade). They are processed into a usable form for direct application.

More information

Medication Administration. By: Carolyn McCune RN, BSN, MSN, CRNP

Medication Administration. By: Carolyn McCune RN, BSN, MSN, CRNP Medication Administration By: Carolyn McCune RN, BSN, MSN, CRNP Percutaneous Administration Medications application to the skin or mucus membranes Ointments, creams, powders, lotions, solutions into the

More information

Define the terms biopharmaceutics and bioavailability.

Define the terms biopharmaceutics and bioavailability. Pharmaceutics Reading Notes Define the terms biopharmaceutics and bioavailability. Biopharmaceutics: the area of study concerning the relationship between the physical, chemical, and biological sciences

More information

UNIVERSITY OF THE WEST INDIES, ST AUGUSTINE

UNIVERSITY OF THE WEST INDIES, ST AUGUSTINE UNIVERSITY OF THE WEST INDIES, ST AUGUSTINE FACULTY OF MEDICAL SCIENCES SCHOOL OF PHARMACY BACHELOR OF SCIENCE IN PHARMACY DEGREE COURSE SYLLABUS COURSE TITLE: COURSE CODE: BIOPHARMACEUTICS, NEW DRUG DELIVERY

More information

SCIENTIFIC DISCUSSION

SCIENTIFIC DISCUSSION This part reflects the scientific knowledge and the information about this product available at the time of prequalification. Thereafter, updates may have become necessary which are included in parts 1

More information

For External Use Only. Should neither be swallowed. Nor injected

For External Use Only. Should neither be swallowed. Nor injected For External Use Only Should neither be swallowed Nor injected Preparations which are applied to the skin. (Topical preparations) Preparations which are applied to the mucus membranes. Local effect Systemic

More information

High-Absorbable Ferric Pyrophosphate for Iron Supplement. Ferrsorb

High-Absorbable Ferric Pyrophosphate for Iron Supplement. Ferrsorb High-Absorbable Ferric Pyrophosphate for Iron Supplement R Ferrsorb Ferrsorb is iron supplement which is absorbed efficiently into the body without impairing taste and texture of various foods. It can

More information

Completion of the development of a formulation: Requirements for compliance check vs. requirements for Marketing Authorisation

Completion of the development of a formulation: Requirements for compliance check vs. requirements for Marketing Authorisation Completion of the development of a formulation: Requirements for compliance check vs. requirements for Marketing Authorisation Workshop on Paediatric Formulations For Assessors in National Regulatory Agencies

More information

Critical material properties for the design of robust drug products : excipient functionality related characteristics

Critical material properties for the design of robust drug products : excipient functionality related characteristics Critical material properties for the design of robust drug products : excipient functionality related characteristics Dr Liz Meehan, Pharmaceutical Development, Macclesfield UK 1 Excipients Definition

More information

Pharma & Food Solutions. POLYOX TM Water Soluble Resins Combining Flexibility with Consistency

Pharma & Food Solutions. POLYOX TM Water Soluble Resins Combining Flexibility with Consistency Pharma & Food Solutions POLYOX TM Water Soluble Resins Combining Flexibility with Consistency POLYOX 9-13 POLYOX 9-13 POLYOX * are nonionic poly (ethylene oxide) polymers that meet all the specifications

More information

Dealing with Uninvited Guests: Excipients. Mark Klang, MS, RPh, PhD, BSNSP Research Pharmacy Manager Memorial Sloan Kettering Cancer Center

Dealing with Uninvited Guests: Excipients. Mark Klang, MS, RPh, PhD, BSNSP Research Pharmacy Manager Memorial Sloan Kettering Cancer Center Dealing with Uninvited Guests: Excipients Mark Klang, MS, RPh, PhD, BSNSP Research Pharmacy Manager Memorial Sloan Kettering Cancer Center Excipients Fillers, solubilizers, preservatives, lubricants, flavoring,

More information

Introduction to. Pharmacokinetics. University of Hawai i Hilo Pre-Nursing Program NURS 203 General Pharmacology Danita Narciso Pharm D

Introduction to. Pharmacokinetics. University of Hawai i Hilo Pre-Nursing Program NURS 203 General Pharmacology Danita Narciso Pharm D Introduction to 1 Pharmacokinetics University of Hawai i Hilo Pre-Nursing Program NURS 203 General Pharmacology Danita Narciso Pharm D 2 Learning objectives Understand compartment models and how they effects

More information

Addendum to the 2016 FAO/WHO Manual on pesticide specifications: revised Tablet Specifications for DT, ST and WT

Addendum to the 2016 FAO/WHO Manual on pesticide specifications: revised Tablet Specifications for DT, ST and WT Addendum to the 2016 FAO/WHO Manual on pesticide specifications: revised Tablet Specifications for DT, ST and WT Introductory Note: The revised model specifications for tablets (ST, WT, DT) have been jointly

More information