ADVANCES IN TECHNOLOGIES FOR FORMULATION DEVELOPMENT OF

STERILE LIQUIDGUIDED BY: PRESENTED BY:

DR. TEJAL SHAH ISHANI PANDIT

HEAD OF DEPARTMENT OF PHARMACEUTICAL 14MPH109

TECHNOLOGY AND M.PHARM, SEM-1.

BIOPHARMACEUTICS, INSTITUTE OF PHARMACY,

INSTITUTE OF PHARMACY, NIRMA UNIVERSITY.

NIRMA UNIVERSITY

CONTENT

• STERILE DOSAGE FORM

• WHAT IS THE NEED TO DEVELOP AN INNOVATIVE STERILE DOSAGE FORM?

• ADVANCES IN DEVELOPMENT OF PARENTERALS

• BFS TECHNOLOGY

• ADVANCES IN FORMULATIONS

• QUALITY CONTROL TESTS

• ADVANCES IN DEVICES

STERILE DOSAGE FORM

A DOSAGE FORM IS SAID TO BE STERILE WHEN IT IS FREE FROM MICROORGANISMS, PATHOGENS AND SPORES.

IN SHORT, IT MUST BE FREE FROM ALL TYPES OF MICROBIAL CONTAMINATIONS.

STERILE PRODUCTS ARE MOSTLY INJECTED, APPLIED ONTO EYE AND ADMINISTERED INTRANASALY.

TYPES OF STERILE DOSAGE FORMS

OPHTHALMIC

INTRANASAL AND PULMONARY DRUG DELIVERY

IMPLANTS

PARENTERAL

OTHERS

WHAT IS THE NEED TO DEVELOP AN INNOVATIVE STERILE DOSAGE FORM?

OPHTHALMIC : TO REDUCE THE FREQUENCY OF ADMINISTRATION AND TO ENHANCE BIOAVAILABILITY.

PULMONARY DRUG DELIVERY : TO REDUCE THE SIDE EFFECTS.

IMPLANTS : TO TARGET THE DELIVERY OF DRUGS.

PARENTERAL : TO MAINTAIN STABILITY OF DRUG AND TO CONTROL THE RELEASE OF POTENT DRUGS.

ADVANCEMENT IN DEVELOPMENT OF PARENTERAL

1. ADVANCES IN DEVICES :

• SELF INJECTION DEVICES

• PEN INJECTORS

• AUTO INJECTORS

• NEEDLE FREE INJECTORS

• NASAL SPRAYS

2. ADVANCES IN FORMULATION

• LIPOSOMES

CONT…

• NIOSOMES

• EMULSIONS – MICROEMULSION/NANOEMULSION

• PEGYLATION

• NANOPARTICLES

• MICROSPHERES

• DENDRIMERS

• IMPLANTS

• DEPOFOAM

• PRODRUG

• DEPOT FORMULATION

BFS TECHNOLOGY

INTRODUCTION: BLOW-FILL-SEAL TECHNOLOGY IS A MANUFACTURING TECHNIQUE USED

TO PRODUCE SMALL, (0.1ML-99ML) AND LARGE VOLUME, (100ML AND ABOVE) LIQUID FILLED CONTAINERS.

BLOW-FILL-SEAL IS A SPECIALISED PACKAGING TECHNOLOGY USING IN-LINE FORMING AND SEALING A POLYMERIC MATERIAL TO A CONTAINER OF CHOICE.

CONCEPT AND WORKING:

THE BASIC CONCEPT IS FORMATION, FILLING AND SEALING OF PLASTIC CONTAINER IN ASEPTIC ENVIRONMENT.

THE BFS CYCLE CAN BE DIVIDED INTO FOLLOWING MAIN STEPS:-

STEP 1: PARISON EXTRUSIONSTEP 2: CONTAINER MOULDING STEP 3: CONTAINER FILLINGSTEP 4: CONTAINER SEALING

Step 1: Parison Extrusion

Firstly, pharmaceutical plastic resin is vertically heat extruded through a

circular throat and forms a tube called Parison.

STEP 2:

CONTAINER MOULDING

• THE EXTRUDED TUBE IS THEN ENCLOSED WITHIN A TWO PART MOULD AND THEN THE TUBE IS CUT ABOVE THE MOULD.

STEP 3:

CONTAINER FILLING

• THE MOULD IS TRANSFERRED TO STERILE FILLING ZONE WHERE FILLING NEEDLES CALLED MANDRELS ARE LOWERED AND USED TO INFLATE THE FLAT TO FORM CONTAINER WITHIN THE MOLD.

STEP 4:

CONTAINER SEALING

• THE MANDREL IS USED TO FILL THE CONTAINER WITH SOLUTION, FOLLOWING FILLING, MANDRELS ARE REMOVED AND SECONDARY TOP MOULD SEALS THE CONTAINER.

NEXT STEP: CONTAINER DISCHARGE

• FILLED AND SEALED CONTAINERS ARE THEN CONVEYED TO LABELLING AND PACKING SECTIONS.

BLOW FILL SEAL PACKAGING MACHINE SYSTEM

CHARACTERISTICS OF BLOW FILL SEAL PROCESS

• THE ISOLATION OF CRITICAL FILLING ZONE WITHIN THE MACHINE.

• STERILE AIR MANAGEMENT WITHIN THIS CRITICAL ZONE.

• IT IS TYPICALLY VERIFIED THROUGH ENVIRONMENTAL MONITORING FOR THE PRESENCE OF NON-VIABLE PARTICULATES.

• BETTER CONTROL OF NON-VIABLE PARTICULATES WILL PROVIDE ENHANCED STERILITY ASSURANCE FOR BLOW FILL SEAL PROCESS.

ADVANTAGES OF BFS

• THE PROCESS TAKES PLACE IN SINGLE MACHINE UNDER A CONTROLLED ENVIRONMENT THAT ENABLES THE PACKAGING OF PARENTERAL SOLUTION IN AN ASEPTIC MANNER WITH FOLLOWING ADVANTAGES:

• OVERALL PRODUCT QUALITY AND PRODUCT OUTPUT.

• LOW OPERATIONAL COSTS.

• HIGH DEGREE OF STERILITY ASSURANCE.

• MINIMUM NUMBER OF OPERATING PERSONNEL.

• RELATIVELY SMALL SPACE REQUIREMENT.

• PROBLEMS REGARDING STORAGE OF EMPTY CONTAINERS IS AVOIDED.

EQUIPMENTS

(A) MANUFACTURING AREA• STORAGE EQUIPMENT FOR AMPOULES, BOTTLES AND CLOSURES

• WASHING AND DRYING EQUIPMENT

• DUST PROOF STORAGE CABINET

• WATER STILL

• MIXING AND PREPARATION TANKS OR OTHER CONTAINERS

• MIXING EQUIPMENT WHERE NECESSARY

• FILTERING EQUIPMENT

• HOT AIR STERILIZER

(B) ASEPTIC FILLING AND SEALING ROOMS• BENCHES FOR FILLING AND SEALING

• BACTERIOLOGICAL FILTERS

• FILLING AND SEALING UNIT UNDER LAMINAR FLOW WORK STATION

CONT…

(C) GENERAL ROOM• INSPECTION TABLE

• LEAK TESTING TABLE

• LABELLING PACKING BENCHES

• STORAGE OF EQUIPMENT INCLUDING COLD STORAGE AND REFRIGERATORS IF NECESSARY

STERILE GARMENT CABINET

• Stainless steel• Ensure a clean storage

space by making use of UV disinfectant and heating through IR lamps.

• These cabinets may be designed in horizontal air flow system and clean air through HEPA filters.

HEPA FILTERS• HEPA FILTERS CAN REMOVE AT LEAST 99.97% OF AIRBORNE PARTICLES

OF 0.3 MICRO METER IN DIAMETER.

• HEPA FILTERS ARE COMPOSED OF MAT OF RANDOMLY ARRANGED FIBRES (POLY- VINYLIDENE FLUORIDE – PVDF)

• KEY METRICS AFFECTING FUNCTION ARE FIBRE DENSITY, DIAMETER AND FILTER THICKNESS.

• THE AIR SPACE BETWEEN HEPA FILTER FIBRES IS MUCH LESS GREATER THAN 0.3 MICRO METER. THE COMMON ASSUMPTION THAT A HEPA FILTER ACTS LIKE A SIEVE WHERE PARTICLES SMALLER THAN THE LARGEST OPENING CAN PASS THROUGH IS INCORRECT.

• SMALLER POLLUTANT PARTICLES MAINLY TRAPPED (THEY STICK TO A FIBRE) BY ONE OF THE FOLLOWING THREE MECHANISMS:

1. INTERCEPTION

2. IMPACTION

3. DIFFUSION

LAMINAR FLOW HOODS• CLEAN AIR WORK BENCHES ARE SPECIALLY

DESIGNED TO ENSURE THE ASEPTIC PREPARATION OF STERILE PRODUCTS.

• AIR FLOW RATES:

• 0.3 M/S(VERTICAL)

• 0.45 M/S (HORIZONTAL)

• INTRODUCTION OF PERSONNEL EQUIPMENT AND MATERIAL INTO THE WORK AREA PROVIDES SOURCES OF PARTICULATE MATTER WHICH MAY CONTAMINATE THE PRODUCT.

• VERY SMALL PARTICLES ARE NOT HEAVY ENOUGH TO SETTLE DUE ONLY TO THE FORCE OF GRAVITY, BUT INSTEAD ARE CARRIED AND DIRECTED BY AIR CURRENTS. AND IF THERE IS TURBULENT AIR, PARTICLES MAY BE DRIVEN INTO PRODUCTS.

• LAMINAR AIR FLOW VELOCITY SATISFACTORILY SWEEPS THE AREA YET DOES NOT CREATE UNACCEPTABLE TURBULANCE

TYPES OF CONTAINERS

1. AMPOULES

• THEY ARE INTENDED FOR SINGLE USE ONLY, BECAUSE GLASS PARTICLES MAY BECOME DISLODGED DURING AMPOULE OPENING, THE PRODUCT MUST BE FILTERED BEFORE IT ADMINISTERED.

LIMITATIONS:

• UNSUITABILITY FOR MULTIPLE DOSE USE.

• THE NEED TO FILTER SOLUTIONS BEFORE USE.

• OTHER SAFETY CONSIDERATIONS.

VIALS

GLASS OR PLASTIC CONTAINERS ARE CLOSED WITH A RUBBER STOPPER AND SEALED WITH AN ALUMINIUM CRIMP.

ADVANTAGES OVER AMPOULES:

• THEY CAN BE DESIGNED TO HOLD MULTIPLE DOSES (IF PREPARED WITH A BACTERIOSTATIC AGENT)

• IT IS EASIER TO REMOVE THE PRODUCT.

• THEY ELIMINATE THE RISK OF GLASS PARTICLE CONTAMINATION DURING OPENING.

DRAWBACKS:

• MULTIPLE WITHDRAWALS (AS WITH MULTIPLE DOSE VIALS) MAY RESULT IN MICROBIAL CONTAMINATION.

DOUBLE CHAMBERED VIALS

• SOME DRUGS THAT ARE UNSTABLE IN SOLUTION ARE PACKED IN VIALS IN POWDER FORM AND MUST BE RECONSTITUTED WITH STERILE SODIUM CHLORIDE INJECTION BEFORE USE.

• SOME OF THESE DRUGS COME IN VIALS THAT CONTAIN A DOUBLE CHAMBER:

TOP CHAMBER – STERILE WATER FOR

INJECTION.

BOTTOM CHAMBER –

UN-RECONSTITUTED DRUG

• BOTH CHAMBERS ARE SEPARATED BY A RUBBER CLOSURE.

• TO DISLODGE THE INNER CLOSURE AND MIX THE CONTENTS OF COMPARTMENTS, EXTERNAL PRESSURE IS APPLIED TO THE OUTER RUBBER CLOSURE

PREFILLED SYRINGES

• DESIGNED FOR QUICKEST ADMINISTRATION AND MAXIMUM CONVENIENCE.

• DRUG ADMINISTERED IN AN EMERGENCY MAY BE AVAILABLE FOR IMMEDIATE INJECTION WHEN PACKED IN PREFILLED SYRINGES.

RUBBER STOPPER WASHING MACHINE

SYRINGE WASHING MACHINE CHARACTERISTICS:

• BARRIER ISOLATORS

• IN-PROCESS CHECK WEIGHING

• FILLING: ROTARY PISTON PUMPS

• 0.2 TO 29 ML

FILLING:

• ALL TYPES OF SYRINGE INCLUDING GLASS, PLASTIC CAN BE FILLED.

• 300 TO 600 SYRINGES IN A MINUTE.

AMPOULE WASHING MACHINE

• WATER IS SPRAYED ONTO THE AMPOULES.

• TURNED TO AN ANGLE OF 180 DEGREE WITH THEIR MOUTH DOWNWARD TO REMOVE WATER.

• FINALLY THE AMPOULES ARE FILLED WITH COMPRESSED AIR TO REMOVE RESIDUAL WATER.

• CERTAIN MACHINES HAVE A HIGH TEMPERATURE ZONE MEANT FOR KILLING ANY BACTERIA.

VIAL WASHING AND STERILIZING MACHINE

AUTOMATIC INTELLIGENT LIGHT INSPECTION MACHINE

VIAL FILLING MACHINE

• FILLS VIALS AND BOTTLES

• LIQUIDS, VISCOUS MATERIAL, SUSPENSIONS AND POWDERS.

PROCESS:

• THE MACHINE COMPRISES OF AN INTAKE SECTION WHICH LOADS THE VIALS.

• TRANSFERRED THROUGH AN INTERMITTENT TRANSPORT SECTION.

• LIQUID FILLING SECTION WHICH FILL THE VIALS WITH PREDETERMINED QUANTITY.

• FINALLY THE FILLED AND RUBBER STOPPERED VIALS ARE RELEASED AND DISCHARGED.

FULLY AUTOMATED INSPECTION SYSTEM

ADVANCES IN FORMULATION

1. LIPOSOMES

• PROMISING IN SUSTAINING THE DRUG RESIDENCE TIME WITHIN LUNG, IMPROVING THERAPEUTIC INDEX, AND DELAYING SYSTEMIC DILUTION AND THEREBY, REDUCING SIDE EFFECTS AND TO CONTROL THE EXTENT OF RELEASE.

• DELIVERY OF CORTICOSTEROID FOR ASTHMA, RIBONUCLEOTIDES FOR RESPIRATORY INFLUENZA AMINOGLYCOSIDES (TOBRAMYCIN SULPHATE, AMIKACIN SULPHATE) AND OTHER ANTIBIOTICS (CIPROFLOXACIN) FOR LOCAL PULMONARY INFECTIONS AND CYSTIC FIBROSIS HAS BEEN REPORTED USING LIPOSOME TECHNOLOGY.

• IN LIPOSOMAL DPI FORMULATIONS, DRUG ENCAPSULATED LIPOSOMES ARE HOMOGENIZED, DISPERSED INTO CARRIER AND CONVERTED INTO DPI BY SPRAY AND / OR FREEZE DRYING.

• ON INHALATION, DRUG ENCAPSULATED LIPOSOME’S GET REHYDRATED IN LUNG AND RELEASE DRUG OVER A PERIOD OF TIME.

• FATTY ACID ESTERS WERE INCORPORATED IN THE LIPID PORTION OF LIPOSOME’S FOR PROLONGED STEROID RETENTION IN THE RESPIRATORY TRACT.

2. NIOSOMES

• THE SUCCESS ACHIEVED WITH LIPOSOMES STIMULATED THE SEARCH FOR OTHER VESICLE FORMING AMPHIPHILES WHICH LED TO THE DEVELOPMENT OF NIOSOMES.

• NON-IONIC SURFACTANTS WERE AMONG THE FIRST ALTERNATIVE MATERIALS STUDIED.

• DRUG TARGETING OF ANTICANCER DRUGS LIKE METHOTREXATE AND DOXORUBICIN HAS BEEN ACHIEVED BY NIOSOMAL FORMULATIONS.

3. IMPLANTS

• IMPLANTS ARE STERILE PREPARATIONS OF A SIZE AND SHAPE SUITABLE FOR PARENTERAL IMPLANTATION AND RELEASE OF THE ACTIVE SUBSTANCE(S) AVER AN EXTENDED PERIOD OF TIME. THESE ARE MADE BY COMPRESSION, MELTING OR SINTERING. THEY GENERALLY CONSIST OF THE DRUG AND THE RATE CONTROLLING EXCEPIENTS.

4. PRODRUGS

• TWO OF THE TECHNOLOGIES BEING EVALUATED AT PRESENT FOR PRO-DRUG APPROACH ARE ANTIBODY DIRECTED ENZYME PRO-DRUG THERAPY (ADEPT) AND THE USE OF POLYMERIC PRO-DRUG.

1. ADEPT:

BASICALLY, AN ANTIBODY – ENZYME CONJUGATE IS ADMINISTERED INTRAVENOUSLY, LOCALIZES IN TUMOUR TISSUE AND SUBSEQUENTLY ACTIVATES AN ADMINISTERED PRO-DRUG PREDOMINANTLY WITHIN SUCH TUMOURS. PRO-DRUG ACTIVATING ENZYME IS CARBOXY PEPTIDASE G2.

2. POLYMERIC PRO-DRUGS:

THIS INVOLVES THE USE OF AN ACTIVE SUBSTANCE AND POSSIBLY A TARGETING MOIETY, BOTH LINKED VIA SPACERS TO A WATER-SOLUBLE POLYMERIC BACKBONE.

FROM THIS BASIC BLUEPRINT, A NUMBER OF POLYMER DRUG CONJUGATED USED FOR CANCER CHEMOTHERAPY AND HAVE BEEN SYNTHESIZED WITH CLEAVABLE DRUG POLYMER LINKERS. THESE INCLUDE SOLUBLE POLYMERIC PRO-DRUGS OF DAUNORUBICIN, DOXORUBICIN, CISPLATIN AND 5-FLUOROURACIL.

5. DEPOFOAM

• DEPOFOAM IS A NON-CLASSICAL LIPOSOME TECHNOLOGY DESIGNED FOR SUSTAINED RELEASE OF THERAPEUTIC AGENTS FOLLOWING INJECTION INTO SITES OTHER THAN THE BLOODSTREAM

• THE TECHNOLOGIES INCLUDE:

1. AERODYNAMICALLY ASSISTEDJETTING

2. ELECTROSTATICALLY ASSISTED SPRAYING

3. COAXIAL AIRFLOW INDUCED DRIPPING

6. DEPOT FORMULATIONS:

• DEPO SYSTEM: SABER DEPOT INJECTION TECHNOLOGY

THE SABER DELIVERY SYSTEM IS AN INJECTABLE, BIODEGRADABLE DRUG DELIVERY SYSTEM THAT USES A HIGH VISCOSITY CARRIER SUCH AS SUCROSE ACETATE ISOBUTYRATE (SAIB) AND ONE OR MORE PHARMACEUTICALLY ACCEPTABLE ADDITIVES.

THE DRUG TO BE DELIVERED BY THE SABER DELIVERY SYSTEM IS DISSOLVED OR DISPERSED IN A SABER SYSTEM FOR SUBSEQUENT INJECTION. UPON INJECTION THE SABER SYSTEM FORMS A DEPOT FROM WHICH THE DRUG IS DELIVERED AT A CONTROLLED RATE OVER PERIODS OF A FEW DAYS TO THREE MONTHS OR MORE. BOTH WATER SOLUBLE AND INSOLUBLE DRUGS OF SMALL AND LARGE MOLECULES CAN BE FORMULATED, STERILIZED AND RELEASED FROM SABER DEPOT INJECTION SYSTEMS.

QUALITY CONTROL TESTS

LEAK TEST

PYROGEN TEST

PARTICULATE TEST

STERILITY TEST

UNIFORMITY OF WEIGHT

UNIFORMITY OF CONTENT

LEAK TEST

• TO DETECT INCOMPLETELY SEALED AMPOULES.

PRINCIPLE:

10% METHYLENE BLUE OR 0.1% FDC RED ONE RED TWO.

GENERALLY COMBINED WITH AUTOCLAVE

DISADVANTAGE:

• LEAKAGE OF 15 MICRON IN DIAMETER OR SMALLER IS NOT DETECTED.

• VIALS AND BOTTLES ARE NOT SUBJECTED TO THIS TEST.

PYROGEN TEST

LAL TESTRABBIT TEST(IP,BP, USP,

EP)

LAL TEST• LITMUS AMOEBOCYTE TEST OR BACTERIAL ENDOTOXIN TEST FOR THE

VALIDATION OF DE-PYROGENATION PROCESS.

• REAGENT – LAL REAGENT (LITMUS POLYPHENUS)

• REACTION – IN PRESENCE OF ENDOTOXIN A FIRM GEL IS FORMED WITHIN 60 MINUTES WHEN INCUBATED AT 37ºC.

CHARACTERISTICS:

• TEST TUBE SCALE.

• ONLY PYROGEN OF GRAM NEGATIVE BACTERIA DETECTED.

• SEMI QUANTITATIVE TEST.

• SENSITIVITY IN TERMS OF ENDOTOXIN UNIT.

• IN-VITRO TEST.

• DOESN’T MEASURE FEVER PRODUCING POTENTIAL OF ENDOTOXIN.

• SENSITIVITY VARIES WITH DIFFERENT MICROBIAL TEST OF LAL.

PYROGEN TEST- FEVER RESPONSE OF RABBIT

• SHAM TEST IS PERFORMED TO SELECT THE PROPER ANIMALS FOR THE MAIN TESTS

• RABBIT TEST – QUALITATIVE FEVER RESPONSE TEST

• PROCEDURE: TEST SOLUTION IS INJECTED INTO THE VEIN OF RABBIT. TEMPERATURE ELEVATION IS SEEN FOR 3 HOURS

DISADVANTAGES:

• BIOLOGICAL VARIATION

• EXPENSIVE

• LABORIOUS

• DOSE DEPENDENT

• NOT FOR ANTI-PYRETIC DRUG.

PARTICULATE TEST

USP

• VISUALLY INSPECTED – ALL (WHITE AND BLACK)

• ANY WITH VISIBLE PARTICLE IS DISCARDED

• LARGE VOLUME PARENTERAL

50 PARTICLES OF 10 MICROMETER

5 PARTICULATES OF 25 MICROMETER PER ML

1. LIGHT OBSCURATION PARTICLE COUNT TEST

2. MICROSCOPIC PARTICLE COUNT TEST

ADVANCES IN DEVICES

1. PRE FILLED SYRINGE

2. PEN INJECTORS

3. AUTO INJECTORS

4. INFUSION PUMP

5. ULTRA SAFE PASSIVE DELIVERY SYSTEM

1. PREFILLED SYRINGE

• DUOJET PREFILLABLE SYRINGE SYSTEMS AND LYOPHILIZED DRUG RECONSTITUTION DEVICES: ITS WORK ON THE ADVANCEMENT OF PARENTERAL TECHNOLOGY, DEVELOPING MEDICAL DEVICES FOR PHARMACEUTICAL CLIENTS WHICH MEET PATIENT NEEDS FOR SAFETY, PRECISION AND SIMPLE EASE OF USE IN DRUG RECONSTITUTION AND DELIVERY

• VARI-VIAL™ PREFILLABLE SYRINGE: VARI-VIAL™ - A PRE-FILLABLE SYRINGE AND NOVEL BOTTOMLESS VIAL CAPABLE OF BEING PROCESSED ON STANDARD 'IN-HOUSE OR OUTSOURCED' VIAL PRODUCTION MACHINERY.

2. PEN INJECTOR

• INSULIN PENS: INSULIN PEN IS THE COMBINATION OF THE SYRINGE AND INSULIN CARTRIDGE INTO ONE.

• IT HAS MADE MULTIPLE INSULIN INJECTIONS MORE CONVENIENT, PORTABLE AND ACCEPTABLE.

• DISPOSABLE AND SEMI-DISPOSABLE INJECTION PENS: PATENTED DISPOSABLE 'DOSE MEMORY' PENS AND 'CLICK-ON' PEN NEEDLES MAKE GIVING INJECTIONS MORE CONVENIENT

3. AUTO INJECTOR

• EPIPEN AND EPIPEN AUTOINJECTORS: EPIPEN AUTO INJECTORS ARE DESIGNED AS EMERGENCY SUPPORTIVE THERAPY FOR ALLERGIC REACTIONS (ANAPHYLAXIS) AND ARE NOT A REPLACEMENT OR SUBSTITUTE FOR IMMEDIATE MEDICAL OR HOSPITAL CARE.

CONT…

• DISPOSABLE AND REUSABLE AUTO-INJECTORS: PROVIDES SAFE AND

EASY INJECTIONS FROM PRE-FILLED SYRINGES.

• PEN INJECTORS- TYPICAL DOSING RANGE 0.01 ML TO 0.08 ML PEN

INJECTORS ARE TYPICALLY MULTI-DOSE INJECTORS USED MAINLY FOR

FREQUENT INJECTIONS. INJECTION PENS ARE USED WITH DEDICATED

DRUG CARTRIDGES AND PEN NEEDLES.

• REUSABLE INJECTION PENS: AVAILABLE WITH EASY TO READ ELECTRONIC

DISPLAYS FOR MULTIPLE DOSING WITH OPTIMAL ACCURACY.

4.INFUSION PUMP

CONT…• INSULIN PUMPS: THE INSULIN PUMP IS A SMALL PORTABLE DEVICE

(ABOUT THE SIZE AND WEIGHT OF A PAGER) THAT DELIVERS INSULIN CONTINUOUSLY THROUGH A FINE PLASTIC TUBE INTO A SITE UNDER THE SKIN. USERS WILL NEED TO GO THROUGH A COMPREHENSIVE TRAINING.

• THE INSULIN PUMP GENERALLY GIVES YOU BETTER CONTROL AND MORE MEAL FLEXIBILITY BUT IS COSTLY AND STILL REQUIRES FREQUENT BLOOD SUGAR MONITORING.

• THE CATHETER AT THE END OF THE INSULIN PUMP IS INSERTED THROUGH A NEEDLE INTO THE ABDOMINAL FAT OF A PERSON WITH DIABETES.

• DOSAGE INSTRUCTIONS ARE ENTERED INTO THE PUMP'S SMALL COMPUTER AND THE APPROPRIATE AMOUNT OF INSULIN IS THEN INJECTED INTO THE BODY IN A CALCULATED, CONTROLLED MANNER.

CONT…• INFUSION PUMPS: COLLEAGUE CX INFUSION PUMP WITH GUARDIAN

FEATURE. FROM SIMPLE INFUSIONS TO MEDICATION THERAPIES REQUIRING COMPLEX DOSE CALCULATIONS.

• GUARDIAN FEATURE TO HELP REDUCE MEDICATION ERRORS BY ALERTING STAFF WHEN PROGRAMMED DOSES ARE NOT MET WITHIN INSTITUTIONAL LIMITS

• PCA II PUMP INNOVATIVE IN PAIN MANAGEMENT: THE CONVENIENCE OF SAFE AND PRECISE PATIENT CONTROLLED ANALGESIA IN A FLEXIBLE SYSTEM DESIGNED WITH ADVANCED TECHNOLOGY. THIS IS PROGRESSIVE, INNOVATIVE, AND EFFECTIVE PAIN MANAGEMENT IN A SOPHISTICATED, YET SIMPLE-TO-OPERATE, INSTRUMENT.

• FLO-GARD 6201 VOLUMETRIC INFUSION PUMP AND THE FLO-GARD 6301 DUAL-CHANNEL VOLUMETRIC INFUSION PUMP: FLOW CHECK OCCLUSION ALARM OFFERS AN IN-LINE RESISTANCE DISPLAY OF INCREMENTAL BACK PRESSURE. FLOW RATE CALCULATION IS AUTOMATIC AFTER VOLUME AND TIME ARE SELECTED.

5.ULTRA-SAFE PASSIVE DELIVERY SYSTEM

ULTRA-SAFE PASSIVE DELIVERY SYSTEM

CONT…

• THE ULTRASAFE® PASSIVE™ DELIVERY SYSTEM OFFERS A COMPLETE PHARMACEUTICAL DELIVERY SYSTEM AS WELL AS AN EFFECTIVE SOLUTION FOR PROTECTING WORKERS FROM THE HORROR OF NEEDLESTICKS.

• SPECIFICALLY DESIGNED FOR PRE-FILLED GLASS SYRINGES, THE ULTRASAFE® PASSIVE™ DELIVERY SYSTEM LEAVES NOTHING TO CHANGE. WITH INNOVATIVE PASSIVE PROTECTION THAT DELIVERS THE ULTIMATE IN SHARPS INJURY PROTECTION AND SAFETY, IT PROVIDES A COMPLETE DELIVERY SYSTEM WITH NO CHANGE IN CURRENT TECHNIQUE.

• ULTRASAFE® NEEDLE GUARDS ARE DESIGNED TO ATTACH EASILY TO MOST PRE-FILLED GLASS SYRINGES COMMONLY USED WITH VACCINES, LOW MOLECULAR WEIGHT HEPARINS AND MANY NEW BIOTECHNOLOGY DRUGS.

THANK YOU