liquid-filled capsules
|
|
- Stella Ford
- 5 years ago
- Views:
Transcription
1 As appeared in September 2017 Tablets & Capsules liquid-filled capsules Liquid-filled hard capsules help meet today s formulation challenges Jnanadeva Bhat, Fernando Diez, and Justin Kalafat ACG While liquid-filled capsule products are not new, they continue to play an important role in the delivery of poorly bioavailable and highly potent APIs. This article provides an overview and summarizes some recent developments. Drug discovery and development have undergone astounding changes in the last few decades, fueled by advances in many areas. Among the most important are cell and molecular biology, recombinant DNA technology, genomics, proteomics, and biochemical and chemical informatics. Better laboratory instruments and automation have also contributed. Likewise, more efficient manufacturing technologies and processes have led to the creation of purer and more potent active pharmaceutical ingredients (APIs). Figure 1 illustrates how the structural complexity and chemical properties of today s APIs compare to substances discovered decades earlier. The oral absorption of an API is fundamentally dependent on the API s aqueous solubility and gastrointestinal permeability. Extensive research into these fundamental properties led to the Biopharmaceutics Classification Systems (BCS), which categorizes APIs into four groups, Class I to Class IV (Figure 2). The BCS assesses compounds based on factors related to oral absorption and on
2 Figure 1 Today s APIs are more complex a. Aspirin (approved 1900) Empty capsules loaded and separated by vacuum Figure 3 Liquid filling process (sealing not shown) No-capsule detection Station for liquid filling Segment & cleaning station (by air and vacuum) Filled capsules discharge Optional station for pellet, tablet, or capsule filling b. Interferon (approved 2001) Capsule cap and body closing station Ejection of unopened capsules Station for liquid filling in vitro measurements of permeability and solubility. In this way, the BCS helps formulators predict the in vivo pharmacokinetic performance of drug products. Permeability Class II Low solubility High permeability Class IV Low solubility Low permeability Figure 2 The BCS [4] Solubility Class I High solubility High permeability Class III High solubility Low permeability Because most of the easy molecules have already been discovered only 5 percent of the APIs under development belong to the Class I (high bioavailability) and 70 percent belong to Class II the bioavailability of today s APIs is typically poor. To improve their bioavailability, it is necessary to increase their solubility. R&D scientists have a number of options to do so, and one of them is use to used lipids in the formulation [1-8]. Lipid-based formulations The principle behind lipid-based formulations is not complicated: It involves dissolving the API in a mixture of solvents. The mixture may comprise triglycerides, mixed glycerides, co-solvents (i.e., polyethylene glycol, propylene glycol), water-insoluble surfactants (i.e., Tween 80), water-soluble surfactants (i.e., Cremophor EH 40), solubility enhancers (i.e., Acconon MC 8/2), and other additives, such as α-tocopherol. For formulators, the key goals are developing a mixture that dissolves the API, increases its bioavailability, and can be placed in a compatible container, typically a capsule. The final steps are identifying a suitable capsule and capsule filler to handle the liquid formulation. In addition to improving bioavailability, lipid-based formulations reduce the food effect. This effect in which the co-administration of the drug product and food affects the absorption of the API could lead to a sub-therapeutic concentration of API in blood plasma (C max ). This is a serious problem for APIs that have a narrow therapeutic index, and where increased bioavailability could lead to serious side effects. Table 1 Method of increasing API solubility [6] Class II Class III Class IV Nanoparticles Select more soluble polymorphs Permeability enhancing excipients Efflux inhibitors Solubility and permeability enhancing excipients Pro-drugs Liquid-filled capsules Pro-drugs Gastroretention Solid dispersions and solutions Add surfactant
3 Figure 4 Capsule suitable for liquid fills Sealing band Liquid medicine because the capsules, after being filled with a liquid, must be sealed and dried. The design of capsules used for liquid encapsulation must also prevent or minimize the formation of bubbles when they are sealed so they do not become banana-shaped. Our company s Flofit capsules are an example of a capsule designed to avoid these problems (page 39). Cap of two-piece hard capsule Body of two-piece hard capsule Filling liquids: Hard versus soft capsules Delivering liquid formulations, including those based on lipids, requires a container, typically either a hard capsule or soft capsule (softgel). Hard capsules have several advantages over softgels, including walls that are typically one-third the thickness of softgel walls. As a result, hard capsules disintegrate faster. And unlike softgels, hard gelatin capsules do not require a plasticizer. Their two main ingredients are gelatin and water, while softgels require glycerin or sorbitol additions to soften the gelatin. Hard capsules are also stable in hot climates, while softgels become tacky and tend to clump. Hard capsules also allow less migration of the fill into the shell, and there is less diffusion of odors. And because hard capsules have fixed dimensions, they are easier to package, especially in blisters, than softgels, whose fill weight can vary throughout a batch, affecting the capsule s size and shape. And while hard capsules accept fills of thermo-stable substances as warm as 80 C, softgel fills are limited to about 35 C, although there is new technology that enables higher-temperature fills in some cases. The important point for formulators to consider when using a hydrophilic carrier is how compatible a hard capsule shell (no plasticizer) would be versus a softgel, which includes plasticizers. Hard capsules are typically made from gelatin or hydroxypropyl methylcellulose (HPMC). While it s beyond the scope of this article to detail the pros and cons of each, their main difference is moisture content. In HPMC capsules, it is lower and as a result, they are more elastic than their gelatin counterparts, which become brittle at low relative humidity. Furthermore, there are two types of HPMC capsules: Those that include a gelling agent and those that do not. Some studies suggest that the absence of gelling agent diminishes the shell s compatibility with liquid solvents, and some scientists have attributed the formation of splits and cracks immediately after banding to these HPMC shells [9-11]. Last, some patients and consumers favor HPMC capsules due to religious beliefs or dietary restrictions that preclude them from consuming a product made from animal parts. To accept liquid fills, hard capsules must have a geometry different from capsules that accept solids. That is Filling machines There is equipment to fill hard capsules with liquids at all scales, from R&D to production. Experimental batches can be filled manually using a hypodermic syringe. This enables formulators to conduct preliminary investigations into the integrity of the capsule shell, its compatibility with excipients, performance in in vitro and in vivo dissolution tests, and its effect on pharmacokinetic properties. Benchtop and production machines operate semi- or fully automatically, and there are few challenges when scaling up for production because increasing the output only requires adding dosing pumps. Look for capsule filling machines that Maintain the product at a constant temperature, up to 80 C, Maintain a homogeneous suspension in the product hopper and filling block, Fill accurate doses at volumes of 0.1 to 1.0 milliliter, Eject the filled capsule body if the cap is missing, Control specific dosing when the cap and body are not separated, Fill liquids over a wide range of viscosity values, and Are compatible with a band sealing machine [12-14]. Sealing Sealing two-piece hard capsules serves two basic purposes: Creation of a leak-proof closure to contain oil, pastes, and other liquids and compliance with the regulatory requirement that over-the-counter capsule products sold in the USA include a tamper-evident feature (FDA s compliance Policy Guide ). The two main sealing methods are application of a gelatin or HPMC band to the cap-body junction and micro-spraying aqueous ethanol into void where the cap and body meet, which fuses the two halves. The advantages of banding include a visible seal, easy leak detection, tamper evidence, and suitability for subsequent coating. Our company s band-sealing machines handle as many as 70,000 capsules per hour [15, 16]. Liquid-filled capsules, today and in the future Liquid-filled capsule products are not new, and there are many on the market. Table 2 lists some of them. Yet the technology is also vital to the success of future drug products. Astra Zeneca, for example, is using hard HPMC capsules for developing AZ6244 (selumetinib) [17]. This API is being developed for the treatment of various cancers. Oramed is developing an oral insulin product that will be delivered in liquid-filled capsules. In April 2017, it was granted a European patent related to
4 Figure 5 Development of a biological API in capsule using lipid-based formulation (SEDDS) [20] Drug Complex Oily droplet Surfactant Emulsifier Co-emulsifier Capsule Oral administration Gl fluid Mucus barrier Absorbtion barrier that product [18.] Chiasma is developing Octreotide, a growth hormone inhibitor for treating acromegaly. Its formulation is based on the company s transient permeability enhancer system, which combines excipients to form an oily suspension of solid hydrophilic particles in a hydrophobic medium. This protects the API and allows it to permeate the gut wall [19]. Much of the work in this area is innovative and challenging. One example is the University of Innsbruck s development of Flip-Flop systems to increase the bioavailability of APIs by changing the zeta potential of the formulation in situ [20]. See Figure 6. Two other areas where liquid-filled capsule technology is expected to grow strongly in the future include highly potent APIs (HPAPIs) for the treatment of cancers, for example and semi-solid formulations. HPAPIs are good candidates for formulation as liquidfilled hard capsules because that format improves safety by lowering the risk of exposure to the HPAPI and the risk of cross contamination. Although HPAPIs constitute a relatively small portion of the API market, they are thought to be one of the fastest growing segments in the pharmaceutical industry. The global HPAPI market is expected to reach $25.86 billion by 2022, with oncology Reproduced with permission of Thiomatrix Table 2 Figure 6 Zeta-potential-changing Flip-Flop system [20] barrier Anionic charge of the mucus therapies the primary driver [21]. Semi-solid formulations are mixtures that take the form of liquids during filling, then solidify in the hard capsule to form a non-porous crystalline plug, or solid dispersion. These formulations can be used to improve not only the dissolution of APIs with low aqueous solubility but also to sustain the release from relatively simple formulations. T&C References 1. Ng R. Drugs: From discovery to approval, 2nd Ed. Wiley-Blackwell Custodio JM et al. Predicting drug disposition, absorption/elimination/transporter interplay and the role of food on drug absorption. Adv Drug Deliv Rev (6): Timko R. Improving the bioavailability of APIs for delivery in oral dosage form. Tablets & Capsules (5): Anilkumar. Solubility enhancement of BCS Class 2 drug by novel drug solution drop technique. May Pharmachitchat.com. Accessed August 11, Browne J. Improving the odds of success during early development using lipid-based systems. February Seminar presentation, San Mateo, CA. 6. Holm R. Lipid suspensions An approach to increase oral bioavailability or just greasy business? Examples of marketed drug products formulated using liquid-filled capsules Active Brand Dosage Form License holder Danthron Co-danthramer Hard capsule Napp Captopril Captopril-R Hard capsule Daiichi Sankyo Pepperment oil Colpermin Hard capsule Janssen Isotretinoin Claravis Hard capsule Teva Mebeverine Mebeverine Hard capsule Mylan Dutasteride/Tamsulosin Combodart Hard and softgel capsule GSK Cyclosporin Neoral Softgel capsule Novartis Ritonavir Norvir Softgel capsule Actavis Reproduced with permission of Thiomatrix
5 March DDF Summit, Berlin, Germany. 7. Mueller EA et al. Influence of a fat-rich meal on the pharmacokinetics of a new oral formulation of cyclosporine in a crossover comparison with the market formulation. Pharm Res (1): Fatouros DG et al. Clinical studies with oral lipid based formulations of poorly soluble compounds. Ther Clin Risk Manag (4): Solaiman A et al. Mechanical properties of capsules shells made of HPMC. April Poster at 6th World Meeting on Pharmaceutics, Biopharmaceutics, and Pharmaceutical Technology, Barcelona, Spain. 10. Bhat J et al. How to assess and prevent brittleness of hard gelatin capsules. Tablets & Capsules (1): Ware E. et al. Investigation of various lipid vehicles in two piece HPMC capsules. October Poster at AAPS Annual Meeting and Exposition, Washington, DC. 12. Podczeck F and Jones B (eds). Pharmaceutical Capsules. Pharmaceutical Press ACG product development department. Liquid filling and band sealing. Not published. 14. Biyani M. Filling of liquid, semisolids and hotmelts into capsules. Not published. 15. Hauss D (ed). Oral lipid based formulations: Enhancing the bioavailability of poorly water-soluble drugs. Informa Healthcare Lightfoot D. An overview of capsule sealing equipment. Tablets & Capsules (1): Evaluation of the use of AZD6244 to induce increased ER expression and anti-estrogen response in ER-negative/low breast cancer. clinicaltrials.gov. Accessed August 11, Oramed granted European patent for combination oral insulin and GLP-1 analog capsule. Oramed Press Release. April Melmed S et al. Safety and efficacy of oral octreotide in acromegaly: Results of a multicenter phase III trial. J. Clin Endocrinol Metab (4): Bernkop-Schnürch A. The mucus gel barrier: Industrial applicable strategies to overcome it. March DDF Summit, Berlin, Germany. 21. Siew A. Liquid encapsulation for HPAPIs. Pharm Tech (1): Jnanadeva Bhat, PhD, is general manager of formulations development, capsules; Fernando Diez is scientific business development manager, capsules; and Justin Kalafat is business development manager, capsules, in North America at ACG. The company operates worldwide. ACG North America is located at 229 Durham Avenue, South Plainfield, NJ Tel Website:
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 informationFORMULATION 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 informationInnovations 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 informationSuppository 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 informationinnovative products. faster to market. reliably supplied.
innovative products. faster to market. reliably supplied. consumer health E DEVELOPMENT DELIVERY SUPPLY We create unique, tailored consumer health solutions to help your brand grow. With more differentiated
More information7. 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>>> Oral Formulation Optimization. Introduction. A Tiered Approach for Identifying Enabling Formulations
Application Note #28-DMPK-3 >>> Oral Formulation Optimization Introduction Among the criteria required of compounds advancing from drug discovery programs, adequate systemic exposure (plasma concentrations
More informationLarge 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 informationCAPMUL + CAPTEX + ACCONON = SEDDS
OUR SOLUTIONS PORTFOLIO ABITEC products are specifically designed for meeting the solubility challenges of the pharmaceutical industry. Our products can be used alone or in conjunction with one another
More informationAccelerating Lipid-Based Drug Formulation Through Application of an Expert System
BAS 418 Eduardo Jule, Ph.D. Senior Manager, Formulation and Pharmaceutical Development Accelerating Lipid-Based Drug Formulation Through Application of an Expert System abstract Formulation scientists
More informationUniversity 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 informationChallenges and solutions for moisture sensitive API formulation
Challenges and solutions for moisture sensitive API formulation Introduction Today, formulators are looking for alternative processes to reformulate existing products or to formulate New Chemical Entities
More informationEnhanced delivery methods for greater efficacy
On-Line Formulation Training - Anywhere In The World - Enhanced delivery methods for greater efficacy Belinda Carli Director, Institute of Personal Care Science Image showing absorbance in the outer stratum
More informationA FACTORIAL STUDY ON THE ENHANCEMENT OF DISSOLUTION RATE OF KETOPROFEN BY SOLID DISPERSION IN COMBINED CARRIERS
Research Article A FACTORIAL STUDY ON THE ENHANCEMENT OF DISSOLUTION RATE OF KETOPROFEN BY SOLID DISPERSION IN COMBINED CARRIERS K. P. R. Chowdary *, Tanniru Adinarayana, T. Vijay, Mercy. R. Prabhakhar
More informationSOFT 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 informationinnovative products. faster to market. reliably supplied.
innovative products. faster to market. reliably supplied. consumer health unique consumer health solutions for otc, supplements & beauty DEVELOPMENT DELIVERY SUPPLY As a global leader in the development
More informationCopyright CSC Publishing
As appeared in Tablets & Capsules January 14 A rapid vehicle-screening approach for formulating a low-solubility compound into liquid-filled capsules formulation Amol Kheur, Anil Kane, Mohammad Aleem,
More informationINTERNATIONAL JOURNAL OF INSTITUTIONAL PHARMACY AND LIFE SCIENCES
International Journal of Institutional Pharmacy and Life Sciences 4(2): March-April 2014 INTERNATIONAL JOURNAL OF INSTITUTIONAL PHARMACY AND LIFE SCIENCES Pharmaceutical Sciences Review Article!!! Received:
More informationInternational Journal of Research in Pharmaceutical and Nano Sciences Journal homepage:
Research Article CODEN: IJRPJK ISSN: 2319 9563 International Journal of Research in Pharmaceutical and Nano Sciences Journal homepage: www.ijrpns.com COMPARARISSION OF SOLUBILITY IMPROVEMENT OF CEFIXIME
More informationEasy, 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 informationSolid 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 informationDevelopment 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 informationDefine 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 informationFunctional Excipients for Suppository Applications
Functional Excipients for Suppository Applications Skin Delivery Platform 2016 1 The Skin Delivery Platform Major areas of activity are in 4 pillars PLATFORM : SKIN DELIVERY Dermal Drug Delivery Mildness
More informationCHEWABLE SOFTGEL TECHNOLOGY
CHEWABLE SOFTGEL TECHNOLOGY PROCAPS AT A GLANCE Procaps is a Pharmaceutical Group dedicated to delivering innovation, health and Nutrition. We work hand in hand with our customers and develop products
More information1. 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 informationFood supplement manufacture
Food supplement manufacture Nick Bennett BSc. RNutr April 2018 1 Introduction There are many different product formats available Liquids, powders, tablets, capsules etc Many different types of machine
More informationEasy, 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 informationThe 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 informationExcipient Considerations for Continuous Manufacturing Implementation
Excipient Considerations for Continuous Manufacturing Implementation FDA-PQRI Conference March 22-24, 2017 David R. Schoneker Director of Global Regulatory Affairs Email: dschoneker@colorcon.com 1 Continuous
More informationFORMULATION 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 informationDelivery systems for nutraceuticals Enhanced bioavailability and improved functionality for lipophilic nutrients
Delivery systems for nutraceuticals Enhanced bioavailability and improved functionality for lipophilic nutrients Potential sales Current sales What is innovation in health? faster onset of action improved
More informationFolic Acid in Human Nutrition
Folic Acid in Human Nutrition Folic acid is a water soluble B vitamin widely distributed in foods. Deficiencies lead to impaired cell division and altered protein synthesis. Newborn children of women receiving
More informationEffect of Common Excipients on the Oral Drug Absorption of Biopharmaceutics Classification System Class 3 Drugs
Effect of Common Excipients on the Oral Drug Absorption of Biopharmaceutics Classification System Class 3 Drugs James E. Polli jpolli@rx.umaryland.edu April 26, 2016 Topics BCS Class 3 excipient study
More informationMylan Laboratories Limited F-4 & F-12, Malegaon MIDC, Sinnar Nashik Maharashtra State, India
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 informationREVISION 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 informationUnigel TM Case Study: Extending Soft Gelatin Capsule Benefits to Novel Fixed Dose Combinations
Unigel TM Case Study: Extending Soft Gelatin Capsule Benefits to Novel Fixed Dose Combinations Diego Monterroza, H. M. Sc, Corporate Manager, R&D Procaps S.A. Stand # 30A46 OUTLINE Fixed Dose Combinations
More informationLubriTose Mannitol Michael Crowley, Director of R&D, Excipients
LubriTose Mannitol Michael Crowley, Director of R&D, Excipients Introduction Michael Crowley Director of R&D Excipients 158 St. Highway 320 Norwich, NY 13815 PH 315-802-5970 Michael.Crowley@Kerry.com 2
More informationCONSIDERATION OF THE END USER AND THE LIMITATIONS DURING THE ORAL ADMINISTRATION DRUG DESIGN: CHALLENGE IN DIFFERENT AGE GROUPS
CONSIDERATION OF THE END USER AND THE LIMITATIONS DURING THE ORAL ADMINISTRATION DRUG DESIGN: CHALLENGE IN DIFFERENT AGE GROUPS Adriana Quiroga Technical Manager Colorcon Latin South America 0 Summary
More informationPHARMACEUTICS 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 informationKolliphor P Grades. Technical Information. Poloxamers for Pharmaceutical Use. = Registered trademark of BASF Poloxamers Ph. Eur.
Technical Information Kolliphor P Grades June 2013 Supersedes issue dated February 2013 03_111136e-03/Page 1 of 8 WF-No. 122937 = Registered trademark of BASF Poloxamers Ph. Eur., Poloxamer USP/NF Poloxamers
More informationExcipients make the difference! Dr. Felicitas Guth Global Technical Service Excipients Pharma Ingredients & Services BASF SE
Excipients make the difference! Dr. Felicitas Guth Global Technical Service Excipients Pharma Ingredients & Services BASF SE Paradigm shift in pharmaceutical development Traditional medicinal products
More informationSoluplus The Solid Solution Opening New Doors in Solubilization.
Soluplus The Solid Solution Opening New Doors in Solubilization. Dr. Shaukat Ali, an enabler in excipients Pharma Ingredients & Services. Welcome to more opportunities. Custom Synthesis Excipients Active
More informationLeader in custom manufacturing. for the pharmaceutical and nutraceutical industries.
Leader in custom manufacturing for the pharmaceutical and nutraceutical industries. Since its inception in April 1994, Viva Pharmaceutical Inc. has built a reputation as a leading manufacturer committed
More informationSTARCH 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 informationTaking Health & Nutrition to the NEXT Level
Taking Health & Nutrition to the NEXT Level 1. Who We are 2. Softigel by Procaps 3. Strategically Located sites Take 10 minutes to get to know us better 4. Our Quality Certifications 5. Product Development
More informationPrincipals and Dosage Forms in the Therapy Modified Drug Release. Institute of Pharmaceutical Technology and Biopharmacy
Principals and Dosage Forms in the Therapy Modified Drug Release Institute of Pharmaceutical Technology and Biopharmacy Dosage forms Definition: Dosage forms are the means by which drug molecules are delivered
More informationCONTENTS 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 informationSCIENTIFIC DISCUSSION. Lopinavir and Ritonavir 200 mg/50 mg Tablets * Name of the Finished Pharmaceutical Product:
SCIENTIFIC DISCUSSION Name of the Finished Pharmaceutical Product: Manufacturer of Prequalified Product: Active Pharmaceutical Ingredients (APIs): Pharmaco-therapeutic group (ATC Code): Therapeutic indication:
More informationLYCOAT. New solutions for Film Coating from Roquette. LYCOAT for quicker quality coating
LYCOAT New solutions for Film Coating from Roquette LYCOAT for quicker quality coating Roquette LYCOAT New solutions for Film Coating from Roquette LYCOAT New solutions for Film Coating Film coating, the
More informationSOMNUS VITM Supplement for sleep and wellness
SOMNUS VITM Supplement for sleep and wellness Unscheduled and non-psychoactive, CANNABINOL represents a major market opportunity as a sedative as well as a potential treatment for insomnia, anxiety and
More informationLIQUID 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 informationSelf Emulsifying Therapeutic System - A Review
ISSN 0976 3333 Available Online at www.ijpba.info International Journal of Pharmaceutical & Biological Archives 2012; 3(3):481-486 REVIEW ARTICLE Self Emulsifying Therapeutic System - A Review Roshan V.
More informationHARD TWO-PIECE HPMC CAPSULES FOR PHARMACEUTICAL APPLICATIONS IN INHALATION
HARD TWO-PIECE HPMC CAPSULES FOR PHARMACEUTICAL APPLICATIONS IN INHALATION 2 3 QUALICAPS HISTORY Over one hundred years of experience in the manufacturing and filling of hard two-piece capsules Qualicaps
More informationRight time, right place: bioactive delivery systems
Right time, right place: bioactive delivery systems Zhigao Niu, Alejandra Acevedo-Fani & Ali Rashidinejad Science of Food Team Riddet Institute, Massey University Developing High-Value Foods Food Systems
More informationformulation John K. Tillotson Abitec (SENDS)
As appeared in July 217 Tablets & Capsules www.tabletscapsules.com formulation An introduction to self-emulsifying nutraceutical delivery systems (SENDS) John K. Tillotson Abitec Like their counterparts
More informationCompletion 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 informationREGULATORY PERSPECTIVE. Dr. Raghunandan H V Associate Professor JSSCP, JSSU, Mysore
1 REGULATORY PERSPECTIVE Dr. Raghunandan H V Associate Professor JSSCP, JSSU, Mysore Contents 2 1. Role of Dissolution Testing in Generic Drug Approval 2. Dissolution Testing Recommendation for Solid Oral
More informationINTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH AND BIO-SCIENCE SELF EMULSIFYING DRUG DELIVERY SYSTEM (SEDDS): A REVIEW
REVIEW ARTICLE INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH AND BIO-SCIENCE A Path for Horizing Your Innovative Work SELF EMULSIFYING DRUG DELIVERY SYSTEM (SEDDS): A REVIEW *NITESH SOLANKI, SNEHAL
More informationWhy and how does a pharmaceutical company take the risk to use novel excipients?
Why and how does a pharmaceutical company take the risk to use novel excipients? M. Sherry Ku, Ph.D. CSO, Anchen Pharmaceuticals Irvine, CA Excipient Fest, May 5, 2010 Puerto Rico Global Excipient Acceptability
More informationDow Wolff Cellulosics. Using ingenuity and savvy. TM Trademark of The Dow Chemical Company ( Dow ) or an affiliated company of Dow
Dow Wolff Cellulosics Pharmaceutical Excipients Using ingenuity and savvy to help design healthcare solutions TM Trademark of The Dow Chemical Company ( Dow ) or an affiliated company of Dow Enhancing
More informationWherever life takes you BASF excipients for orally disintegrating tablets make medication easy
Wherever life takes you BASF excipients for orally disintegrating tablets make medication easy Dr. Philipp Hebestreit, an enabler in excipients Pharma Ingredients & Services. Welcome to more opportunities.
More informationBCS: Dissolution Testing as a Surrogate for BE Studies
BCS: Dissolution Testing as a Surrogate for BE Studies Dirk M Barends National Institute of Public Health and the Environment The Netherlands APV / IKEV Seminar on Bioavailability and Bioequivalence, Istanbul,
More informationAssessment 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 informationDetermination 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 informationWater-free Anionic Surfactants
SEPAWA Nordic Conference May 5, 2014 Malmö, Sweden Udo Schoenkaes Sasol Germany GmbH Water-free Anionic Surfactants Innovative Ingredients for Modern Cleaning Systems Water-free Anionic Surfactants AES-MIPA
More informationTablet 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 informationB. semisolid materials consisting of hydrophilic and hydrophobic portions
CHEM 470 Understanding Emulsions I. Definitions A. Any heterogeneous system which has at least one immiscible or barely miscible liquid dispersed in another liquid in the form of tiny droplets. A. Becher,
More informationCritical 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 informationDr.N.Damodharan Professor and head Department of pharmaceutics SRM college of pharmacy
Dr.N.Damodharan Professor and head Department of pharmaceutics SRM college of pharmacy Suppositories are solid dosage forms intended for insertion into body orifices where they melt, soften, or dissolve
More informationWE VE GOT THE POWDER THE KEY TO YOUR NEW MEDICATED CHEWING GUM
WE VE GOT THE POWDER THE KEY TO YOUR NEW MEDICATED CHEWING GUM Health in Gum is a powdered excipient specially designed to formulate and produce medicated chewing gum It combines gum base and sweeteners
More informationSUMMARY 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 informationDefoaming Surfactants
TERGITOL L Series Biodegradable Surfactants TERGITOL L-61 E, L-62 E, L-64 E, L-81 E Defoaming Surfactants Trademark of The Dow Chemical Company ( Dow ) or an affiliated company of Dow. These surfactants
More informationChemate and Chowdary, IJPSR, 2012; Vol. 3(7): ISSN:
IJPSR (2012), Vol. 3, Issue 07 (Research Article) Received on 18 March, 2012; received in revised form 25 April, 2012; accepted 22 June, 2012 A FACTORIAL STUDY ON ENHANCEMENT OF SOLUBILITY AND DISSOLUTION
More informationSPS Pharma: Who we are?
Applications in area of drug release using the flow through cell Society of Pharmaceutical Dissolution Science 26-27th July 2016 Ahmedabad (India) Samir Haddouchi samir.haddouchi@sps-pharma.com www.sps-pharma.com
More informationNovel drug delivery system. Nanos-in-Micros
Novel drug delivery system Nanos-in-Micros Janne Raula The annual symposium of the Finnish Society of Physical Pharmacy February 9 th, 2012 Medicinal treatment Indications -Neurosurgery -General surgery
More informationSTARCHES FOR COSMETIC INDUSTRIES CORN PO4 PH B AND RICE NS
STARCHES FOR COSMETIC INDUSTRIES CORN PO4 PH B AND RICE NS AGRANA STARCH QUALITATIVE OPTIMIZATION OF COSMETIC EMULSIONS WITH CORN PO4 PH B OR RICE NS For many years CORN PO4 PH B and RICE NS (cross-linked
More informationIndustrial 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 informationThe right impact on taste and texture CONDITIONING COATING BROCHURE
The right impact on taste and texture CONDITIONING Consumer trend The trend in today s consumer market is strongly focused on high quality cheese. Besides, consumers show a clear interest in authentic
More informationChallenges in Developing Stable and Efficient Probiotic Formulations
Challenges in Developing Stable and Efficient Probiotic Formulations Morgan Laloux morgan.laloux@capsugel.com +32 491 73 20 53 Summary Challenges in Formulating Probiotics Formulating Probiotics in Capsules
More informationDifferentiate your brand. with the unique look and performance of capsugel s press-fit and xpress-fit gelcaps. capsugel.com
Differentiate your brand with the unique look and performance of capsugel s press-fit and xpress-fit gelcaps capsugel.com Imagine the possibilities Breathe new life into existing product lines. Build your
More information905 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 informationMETOLOSE: CONTENTS PAGE
METOLOSE: CONTENTS PAGE 2 Preface What is Metolose Substitution types Specifications 1) Available grades & viscosity 2) Nomenclature 3) Packaging Characteristics of Metolose Properties of Metolose 1) Powder
More informationCompounding 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 informationEdible Films, Coatings & Processing Aids
Edible Films, Coatings & Processing Aids Mikal E. Saltveit Mann Laboratory, Department of Plant Sciences, University of California, Davis, CA 95616-8631 Use of Edible Films and Coatings Reduce water loss
More informationFROM SOLVENT TO AQUEOUS COATINGS. (Out of the Frying Pan...) Ralph E. Pondell. Coating Place, Inc. P.O. Box
84-1 FROM SOLVENT TO AQUEOUS COATINGS (Out of the Frying Pan...) Ralph E. Pondell Coating Place, Inc. P.O. Box 930310 Verona, WI 53593 A number of reasons exist for the current high level of interest in
More informationProtection and Processing of a Highly Hygroscopic Herbal Extract by Drug Layering and Film Coating
NUTRAFICIENT Application Data Food Supplement Coating Protection and Processing of a Highly Hygroscopic Herbal Extract by Drug Layering and Film Coating OBJECTIVE To stabilize a highly hygroscopic herbal
More informationANNEXURE -2. Excipients profiles of Compritol ATO 888, Gelucire 43/01, HPMC and PVP and have been described in the following section.
2. EXCIPIENTS PROFILES ANNEXURE -2 Excipients profiles of Compritol ATO 888, Gelucire 43/01, HPMC and PVP and have been described in the following section. 2.1. COMPRITOL 888 Non proprietary names BP:
More informationA FACTORIAL STUDY ON ENHANCEMENT OF SOLUBILITY AND DISSOLUTION RATE OF IBUPROFEN BY β CYCLODEXTRIN AND SOLUTOL HS15
INTERNATIONAL JOURNAL OF RESEARCH IN PHARMACY AND CHEMISTRY Available online at www.ijrpc.com Research Article A FACTORIAL STUDY ON ENHANCEMENT OF SOLUBILITY AND DISSOLUTION RATE OF IBUPROFEN BY β CYCLODEXTRIN
More information2- Minimum toxic concentration (MTC): The drug concentration needed to just produce a toxic effect.
BIOPHARMACEUTICS Drug Product Performance Parameters: 1- Minimum effective concentration (MEC): The minimum concentration of drug needed at the receptors to produce the desired pharmacologic effect. 2-
More information21 st Century Challenges in Fertilizer Coatings
21 st Century Challenges in Fertilizer Coatings Mark Ogzewalla, Technical Manager ARRMAZ Mulberry, Florida, USA DUSTROL GALORYL Definition: Coating is a surface treatment applied to solid fertilizers Solid
More information02/09/2016. Roles of Excipients in Pharmaceuticals:
Definition: Any substance other than the active drug or prodrug that is included in the manufacturing process or is contained in a finished pharmaceutical dosage form. Excipients are not inactive and have
More informationIn-Vitro Bioequivalence Studies for Oral Solid Dose products using the Morphologi G3-ID
In-Vitro Bioequivalence Studies for Oral Solid Dose products using the Morphologi G3-ID PARTICLE SHAPE MOLECULAR SIZE CHEMICAL IDENTIFICATION Introduction A generic drug is defined as being "identical
More information13. SUPPOSITORY Suppository Bases. The active substance is prepared in a suitable bases. An ideal suppository bases should carry:
13. SUPPOSITORY They are solid single-dose preparations whose shapes, volumes and consistencies are suitable for rectal administration. There are also such vaginal preparations in the treatment of local
More informationNew formulas for successful drug delivery Hot-melt extrusion for enhanced solubility and bioavailability
New formulas for successful drug delivery Hot-melt extrusion for enhanced solubility and bioavailability Andreas Gryczke, an enabler in excipients Pharma Ingredients & Services. Welcome to more opportunities.
More informationIs 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 informationSenior Scientist / Principal Scientist. Compounding Manager (Sterile and non-sterile specials) Senior Pharmaceutical Assessor
Curriculum Vitae PERSONAL INFORMATION Andrew Twitchell WORK EXPERIENCE May 1987 September 1991 Senior Scientist / Principal Scientist 3M Health Care Ltd, (United Kingdom) Formulation, scale-up and manufacture
More informationSCIENTIFIC 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
More informationSCIENTIFIC DISCUSSION
SCIENTIFIC DISCUSSION Name of the Finished Pharmaceutical Product: Manufacturer of Prequalified Product: Active Pharmaceutical Ingredients (APIs): Pharmaco-therapeutic group (ATC Code): Therapeutic indication:
More informationPartner with the Global Leader in Drug Delivery Systems
3M DRUG DELIVERY SYSTEMS Partner with the Global Leader in Drug Delivery Systems Loughborough, United Kingdom Manufacturing Facility Experts at Commercializing Innovation 3M: Transforming New Ideas into
More information