Preparation and characterization of gelatin- tamarind gum ...
ONE SINGLE TECHNOLOGY - MEDISCA · 2017-04-12 · | 1.800.932.1039 6 4 NEW! MELTING EFFECTIVENESS...
Transcript of ONE SINGLE TECHNOLOGY - MEDISCA · 2017-04-12 · | 1.800.932.1039 6 4 NEW! MELTING EFFECTIVENESS...
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O N E S I N G L E T E C H N O L O G Y MULTIPLE CAPABILITIES
MIXING | DEAERATION | MELTING | MILLING
Financing Options Available Contact Your Account Executive
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MEDISCA PRESENTS THE MAZERUSTAR MIXER Combining the need for both speed and content uniformity, the Mazerustar provides pharmacists with a revolutionary way to compound. The Mazerustar’s easy-to-use interface means less room for error, while its unique planetary motion allows you to provide your patients with high-quality formulations.
FEATURES AND BENEFITS• NEW: Excellent for milling powders• NEW: Ideal for melting gelatin gum base for
troches and chewy treats• Suitable for hazardous drug compounding due to
closed system mixing; meets USP <800> requirements• No mixing rods or blades; reduced risk for cross
contamination • Ideal for mixing creams, gels, ointments and liquids • Includes a vacuum-like feature to help remove
air entrapment• High speed mixing motion• Capable of mixing 250 g in 30 seconds (KK-300SS model)• Ensures homogeneous formulations (< 4% RSD)• Operates with redundant safety features• Reusable and disposable containers allow for quick
and easy clean-up• Saves you time and money with efficient mixing process • Lightweight, bench-top model, weighing approximately
24 Kg (KK-300SS model)• The Mazerustar is also available in other model sizes:
KK-1000W (1 Kg x 2 containers) and KK-2000 (2 Kg x 2 containers)
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A REVOLUTION IN ITSELFThe Mazerustar performs mixing and deaeration simultaneously by revolving and rotating the container concurrently. This unique motion eliminates the need for mixing rods, blades, and an evacuation device, thus dramatically reducing processing times.
1 Rotation
2 Revolution
The unique features of the Mazerustar as a mixing/deaeration device are protected by Japanese public patents (No. 2711964 and No. 3213735).
JUST WHEN YOU THOUGHT WE HAD ASCENDED TO THE PEAK OF MIXING TECHNOLOGY FOR COMPOUNDERS
KK-400W (400 g x 2 containers)
KK-300SS (300 g x 1 container)
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THE MAZERUSTAR PUT TO THE TEST
1 QUALITATIVE RESULTS
Representative formulas in a number of therapeutic categories were mixed with the Mazerustar and visually inspected for uniformity. Before and after photos below tell us what is happening on the surface.
2 QUANTITATIVE RESULTS
A stability-indicating, high pressure liquid chromatography (HPLC) method was developed by a third party laboratory in accordance to USP chapter <1225>.
A measure of mixing efficacy, HPLC tells us what is happening below the surface. Concentration gradients at multiple layers were analyzed and percent relative standard deviations (%RSD) were determined. In the example shown to the right, RSD is 3% or less, and in some cases as low as 0%.
1.9%
1.9%
1.9%
BACLOFEN DICLOFENAC NaBUPIVACAINE HCl CYCLOBENZAPRINE HCl
5.2%2.1% 9.1%
5.0%2.1% 9.0%
5.3%2.1% 9.3%
TOP
MIDDLE
BOTTOM
RSD = 0% RSD = 0% RSD = 3% RSD = 2%
250 g formulation mixed at maximum speed, for 30 seconds, with levigated material on top
OINTMENT BASE + DYE• Time: 30 seconds• Temp.: 23.0oC
OINTMENT BASE + DYE• Time: 30 seconds• Temp.: 25.8oC
Preparations were examined for content uniformity using dye tracer, ensuring colorant was evenly distributed from top, through to middle, and all the way to the bottom.
BEFORE PROCESSING AFTER PROCESSING
THE UNIQUE PLANETARY MOTION OF THE MAZERUSTAR BRINGS PRODUCT QUALITY TO THE NEXT LEVEL
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3 DEAERATION CAPABILITY
Is air entrapment a concern in your preparations? The built-in vacuum-like capability of the Mazerustar solves this issue by evacuating suspended air bubbles within the preparation. No other machine can mix and deaerate at the same time making the Mazerustar the first of its kind on the market!
Degas Mode Time Temperature Before Temperature AfterVersaPro™ Gel Base 60 seconds 22.9oC 23.3oC
THE MAZERUSTAR MIXER ENABLES YOU TO CREATE COMPLETELY HOMOGENIZED AND UNIFORM FORMULATIONS
Before: Suspended air bubbles in VersaPro™ Gel Base
10X
MIXED BY CONVENTIONAL METHOD
After: No visible air bubbles in VersaPro™ Gel Base
10X
DEAERATED WITH MAZERUSTAR
HOW CAN AIR ENTRAPMENT AFFECT YOUR PATIENT?
Speaking specifically about deaeration, we need to consider how the patient perceives a topical prescription given to them that still contains air or gas bubbles. In instances where the preparation is packaged in a metered-dose measuring device, we risk under dosing the patient if any air bubbles are trapped in the preparation. At the same time, if the patient is used to what the administered metered-dose volume looks like, they may administer another actuation, thinking there is an issue with the packaging device. This can potentially result in an over dosage to the patient. When patients receive preparations that are consistently uniform in appearance and administration, not only do they feel that the pharmacy staff took time and care into the customization of their prescription but also, they are filling their prescriptions at a pharmacy that they can rely and depend on to deliver quality preparations.
Mindy Cormier PharmD, RPh
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MAZERUSTAR RETURN ON INVESTMENT ANALYSIS
The Mazerustar Mixer provides an excellent return on investment (ROI) for pharmacists and business owners. Depending on the number of prescriptions your pharmacy processes per day, you can expect to see a complete return of your initial investment within only a few short months, as illustrated in the tables below.
• Hourly Cost of Overhead $15.00
• Hourly Cost of Technician Labor and Benefits $25.00
• Labor Time excludes Levigation and Trituration
COMPOUNDING PHARMACY (50 TOPICAL SCRIPTS PER DAY)
Mixing Method (Incl. Cleaning)
Avg. Labor Time in Minutes per Script
Daily Labor in Minutes (50 Scripts)
Yearly Minutes (245 Days)
$/Year ($40 per Hour)
CONVENTIONAL METHOD 16.10 805 197,225 $131,483
MAZERUSTAR MIXER 1.08 54 13,230 $8,820
LABOR SAVINGS PER YEAR 751 183,995 (3,067 hours) $122,663
ROI FOR PURCHASE PRICE OF $17,000 1.7 months
COMPOUNDING PHARMACY (20 TOPICAL SCRIPTS PER DAY)
Mixing Method (Incl. Cleaning)
Avg. Labor Time in Minutes per Script
Daily Labor in Minutes (20 Scripts)
Yearly Minutes (245 Days)
$/Year ($40 per Hour)
CONVENTIONAL METHOD 16.10 322 78,890 $52,593
MAZERUSTAR MIXER 1.08 22 5,390 $3,593
LABOR SAVINGS PER YEAR 300 73,500 (1,225 hours) $49,000
ROI FOR PURCHASE PRICE OF $17,000 4.2 months
IMPROVE YOUR BOTTOM LINE WITH THE MAZERUSTAR MIXER Mixing Method Cost Per Script
CONVENTIONAL METHOD $10.73
MAZERUSTAR MIXER $0.72
HOW WILL THE MAZERUSTAR MIXER IMPACT YOUR BOTTOM LINE?
FINANCING OPTIONS AVAILABLE
OWN YOURSTODAY!
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4 NEW! MELTING EFFECTIVENESS (GELATIN GUM)
The Mazerustar mixer also offers a simplified and more efficient way to melt gelatin gum base for your gelatin-based dosage forms without the need for beakers or a hot plate.
RESULTS
After 2 minutes, the gelatin gum base is partially melted and the API(s) can be easily incorporated. After 1 additional minute of mixing, the final mixture is homogeneous and of pourable consistency making it easy to mold into troches, gummies or chewable veterinary treats. Melting is achieved without exceeding 50oC versus conventional methods which require heating the base up to 65oC.
CHEWY TREATS AND TROCHES ROI
• Hourly Cost of Technician Labor and Benefits $25.00
COMPOUNDING PHARMACY (50 CHEWY TREAT SCRIPTS PER DAY)
Mixing Method (Incl. Cleaning)
Avg. Labor Time in Minutes per Script
Daily Labor in Minutes (50 Scripts)
Yearly Minutes (312 Days)
$/Year ($25 per Hour)
CONVENTIONAL METHOD 20 1,000 312,000 $130,000
MAZERUSTAR MIXER 3 150 46,800 $19,500
LABOR SAVINGS PER YEAR 850 265,200(4,420 hours) $110,500
ROI FOR PURCHASE PRICE OF $17,000 1.8 months
REDUCE PREPARATION TIMES OF TROCHE AND CHEWY TREAT FORMULATIONS
Gelatin gum base in initial state before melting.
Gelatin gum base mixed for 2 minutes before adding an API or flavor.
Gelatin gum base mixed for an additional minute giving its final melted state.
Final melted gelatin gum poured into troche mold for final dispensing.
2 MINS. 1 MIN.
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Sodium Chloride, USPPARTICLE SIZE: 50% < 351 µm
10% < 223 µm
Sodium Chloride, USP in stainless steel liner with milling beads.
Sodium Chloride, USP milled for 1 minute.
Mortar & pestle then mixed via conventional methods showing a gritty and airy preparation.
Milled and mixed in Mazerustar giving a smooth and deaerated preparation.
TRITURATE NO MORE WITH THE USE OF MILLING MEDIA
5 NEW! MILLING CAPABILITY
Eliminate time-consuming trituration by replacing your mortar and pestle with the Mazerustar. Using Zirconia milling media, a coarse granular powder can be transformed into ultra-fine particles in 60 seconds.
Grittiness in the final preparation can be greatly reduced or eliminated by reducing particle size of the powders in the Mazerustar before mixing. This streamlined process reduces variability in your final compound as well as employee wear and tear.
Sample formulas are available upon request.
RESULTS OF PARTICLE SIZE DISTRIBUTION *
Volu
me
(%)
Particle Size (µm)0.10.1
0246
8
101214
16
18
1 10 100 1000
Trituration with Mortar & Pestle (60 sec)PARTICLE SIZE: 50% < 329 µm
10% < 171 µm
0.10
1
2
3
4
5
6
1 10 100 1000
Volu
me
(%)
Particle Size (µm)
Milling in Mazerustar (60 sec)PARTICLE SIZE: 50% < 43 µm
10% < 8.2 µm
VS.
* Particle size results generated using the Malvern Mastersizer 2000
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FREQUENTLY ASKED QUESTIONSQ Is the Mazerustar available in other sizes?A Yes, there are multiple models ranging in capacities from 250 g to
20 Kg. MEDISCA has selected the KK-300SS as its benchmark model, as it is suitable for most compounding practices. All models use the same planetary mixing technology with mixing / deaerating settings optimized for each. MEDISCA is exclusive for the entire line of Mazerustar mixers and can source any model required.
Q What are the most ideal applications for the Mazerustar?A Mixing creams / gels / ointments i. Compounded preparations with hormones. ii. Multi-API formulations. iii. Low concentration API formulations. Mixing liquids i. High-viscosity liquids which are normally difficult to mix or which
require long processing time by conventional mixing machines. ii. Suspensions: Mixing liquids and powders which need to be
evenly mixed even if their characteristics and specific gravities are widely different.
Deaeration i. With its built-in vacuum-like feature (degas mode), you can
remove entrapped air, resulting in a beautifully elegant product for the pharmacist, and accurate dispensing of the medication for the patient.
Melting i. The rotation of the unit for 3 minutes generates enough heat to
melt Gelatin Gum Base at a max temperature of 50oC. Milling i. Adding the Zirconia milling beads with a stainless steel liner will
allow you to micronize your powders thus replacing the process of trituration.
Q What are the milling accessories required for Mazerustar? A
Q Can the Mazerustar be used to mix powders?A Given its high G-forces, the Mazerustar can thoroughly mix powders,
but in limited quantities. For the KK-300SS, a maximum of 25 g can be thoroughly mixed in 30 seconds. For optimal and effective mixing of larger amounts of powders, MEDISCA recommends the Inversina mixer; a cost-effective solution allowing you to mix up to 2 L of powders.
Q How loud is the Mazerustar?A Under maximum capacity and speed, at a distance of 1m, the
KK-300SS has an operating volume of approximately 65 dB. To put this in context, it is comparable to the volume of a verbal conversation.
Q What are the applicable working parameters for a 250 g formulation? (Applicable to KK-300SS model.)
A Mixing: Creams, gels, ointments, liquids, and suspensions can all be mixed in 30 seconds with minimal heat generation. For the KK-300SS, an operator would rarely use mixing times in excess of 2 minutes.
Deaeration: Cream, gels, and ointments can be deaerated in 1 minute with minimal heat generation.
Melting: Gelatin Gum Base can be melted in 3 minutes.
Milling: Powder micronization can be achieved in 1 minute.
Q What evidence does MEDISCA have to support the Mazerustar Mixer?
A Mixing: A stability-indicating High Pressure Liquid Chromatography (HPLC) method was developed to determine the exact concentration of each API within different layers of the preparation.
Deaeration: Pycnometer measurements to confirm that the specific gravity of topical preparations can be restored after entrapped air is removed.
Milling: Quantitative measurements using the Malvern Mastersizer machine.
Q What is the lead time to receive a Mazerustar Mixer?A For smaller capacity units, the lead time is 5 business days if in stock.
If model is out of stock, expect a 3-4 week lead time. For larger capacity units, typical lead time is 4-6 weeks.
Q What are some precautions to take when using the Mazerustar?A All mixing / deareating procedures should be performed using the
mixing containers provided. Do not use any other jars, unless a custom adapter is in use.
Q Can I incorporate the Mazerustar with my HD compounding?A Yes, the Mazerustar and mixing jar provides a closed system to mix
all your preparations.
Q Does MEDISCA provide a video or instructional material?A Yes, a video explaining features of the Mazerustar along with a demo
can be found on our website at www.medisca.com. Specification sheets and brochures can also be downloaded from our website.
Q What are other potential capabilities of the Mazerustar?A i. Custom adapters are being developed to allow for mixing in
different types of containers (EMP jars, pump bottles, syringes, etc). ii. Crushing uncoated tablets using stainless steel liner and zirconia
milling beads.
MIX. DEAERATE. MELT. MILL. WELCOME TO THE FUTURE OF COMPOUNDING
Stainless Steel Liner Product No. 6416
Zirconia Milling Beads Product No. 6415