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Granulation Drying & Blending ( GDB ) - Effervescent Product Solutions

Mark Maker Pharma provides complete Effervescent Product Solutions in Mumbai for Effervescent Products like effervescent tablet and many more. The effervescent tablet has proven to be very user friendly dosage form for intake of pharmaceuticals. For the pharmaceutical industry, effervescent tablet represents a mean to expand product lines, long product life cycle and more stability. The effervescent services we offer are highly considerate and qualify all the industry norms and grades that are essential.

The MMPE VACUUM GRANULATION is based on the granulation process which can be controlled by repeatedly applying a vacuum during the procedure, thus producing an effervescent tablet which is quickly and completely soluble and at the same time extremely resistant to humidity. Addition of flavour can be done during the process.

Effervescent tablets have become a preferred dosage form for applying active pharmaceutical ingredients (APIs), especially for pain relief. Convenient intake, quick onset of action and good tolerance favor this dosage form. The possibilities of providing pharmaceuticals with a specific flavor and API taste masking are important criteria. Because patients take the API in a dissolved form, an unpleasant taste can be immediately detected. We are thus considered one of the finest in the category that offers complete Effervescent Product Solutions in Mumbai.

The development of effervescent tablets requires extensive technical expertise on the part of the manufacturer. Specific experience, not only with regard to formulation development, but also regarding taste masking and subsequent manufacturing, is required.

GDB granulation technology comprises a one-step vacuum system, under fully instrumented in- process control (IPC). The process modifies the surface of carrier materials with resultant alterations in their binding mechanisms. Effervescent Tablets from these granules have excellent hardness and stability.

GDB granulation requires only a very small quantity of liquid to start the chain reaction.

In contrast to other technologies that require e.g. acetone, or water-ethanol mixtures for granulation. As a result, there are no solvent residues in the finished products.

Effervescent Product Solutions
MMPE Vacuum Granulation Vs Conventional Manufacturing Techniques:

For the production of effervescent tablets various manufacturing methods are in use:

Conventional manufacturing of effervescent tablets

The most important aspect in the conventional manufacturing of effervescent tablets is the exact control of the relative humidity during the process. If the relative humidity at a temperature of ca. 21 °C stays below 20 percent, various manufacturing procedures for perorally administered tablets are in principle applicable. In this case, direct compression, dry granulation and granulation with, e. g., fluid bed granulators are possible

1 Direct compression

Direct compression is the best option for low price products. Especially with food supplements, direct compression is the most common procedure. Binders such as dextrose, sorbite and others need to be added in quantities of at least 200 mg per tablet. However, large quantities of sugar alcohols can have adverse effects, e. g., cause diarrhea. Spray drying of acid salts (e.g., monosodium citrate) is an alternative method of direct compression. Effervescent tablets manufactured with this process, however, have low mechanical stability.

For the above mentioned reasons, it is advisable to granulate the components before tableting and thus produce a stable, high quality product.

2 Dry granulation

Dry granulation requires the internal addition of water soluble lubricants. The acidic and alkaline components can be processed either together or separately. Dry granulation is generally acceptable for moisture sensitive substances and cost-effective due to high throughput rates. In the manufacture of effervescent tablets this method is used rarely, as effervescent tablets manufactured this way possess low mechanical and chemical stability in comparison to those produced by the granulation procedures in fluid bed Dryer.

3 Fluid bed granulation

With fluid bed granulation, the acidic and alkaline components can be granulated together or separately. When granulated separately, the ad­ dition of organic solvents is not nec­ essary. However, when granulated to­ gether, organic solvents such as iso­ propanol or ethanol are required to prevent the effervescent reaction from starting immediately and un­ controlled. Small quantities of water can be added as the granulation and the drying process take place in one step. It is important that only small water quantities are added to be able to control the reaction. The addition of organic solvents entails higher safety requirements in manufactur­ ing and added environmental im­ pact. This leads to higher costs, not to mention the enormous energy ex­penditure involved in the air conditioning required for this process.

Salient Features:
  • This machine provides many helpful features to and efficiency and safety during the mixing process.
  • Mark Maker a pioneer in applying GBD vacuum granulation. This procedure comprises a synthetic granulation to enlarge the particles and increase their stability resulting in a granulate which is easy to tabletize and extremely moisture resistant. By granulating in a vacuum, an uncontrolled chain reaction is prevented. This procedure is the basis for all effervescent tablets produced.
  • Easy to charge the material into the GDB receptacle (manually or mechanically)
  • Easy discharge through a manually operated manhole at the bottom with effect of tilting position.
  • Automatic operation of the granulation drying & blending cycle through pre-set timer.
  • All powder contact surfaces in S.S. 316 mirror polished
  • The product arising from GBD granulation dissolves quickly in water, as the release of carbon dioxide in water starts immediately. At the same time it is extremely moisture resistant which enables a long shelf life of the finished product and its use also in tropical regions; products for even countries in climatic zones IV+ can be supplied without difficulty. The citrate coating facilitates increased stability against acid- . sensitive agents. As also alkaline agents can be coated, this benefit is equally effective for agents sensitive to alkali. Manufacturing can take place at a relative humidity of 30 percent within the room
  • The atmospheric pressure lowered by the vacuum leads to reduced drying temperatures and shorter drying times. Fill capacities of about 500 kg granulate can generally be dried within 15 minutes.
  • GBD granulation provides a transparent solution of the paracetamol effervescent tablet with very homogenous distribution of the API. As the flow characteristics improve due to enlarged particles and thus also the dosage accuracy, a homogenous distribution of the agent is achieved without additional blending enabling more efficient manufacture.
  • The effervescent tablets disintegrate quickly, even if stored over a long period. The quick and transparent dissolution of the paracetamol is achieved by the addition of surface-active agents, as well as the above described granulation of the paracetamol with the effervescent components. We offer a complete package Effervescent Product Solutions in Mumbai.
Benefits
  • Uniform granule size with very even distribution of binder.
  • There is no lump formation as binder solution is sprayed as a very thin mist. By this way avoiding milling and again sizing steps.
  • Vacuum drying provides the advantage of drying of material at lower temperatures than drying without vacuum. Useful for materials having low melting point.
  • Cooling oil circulation is provided to avoid over drying during blending.
GDB granulation procedure

The GDB granulation is a process utilized for the manufacture of effervescent granulate containing at least one organic acid (e. g., citric acid) and at least one alkaline carbonate (e. g., sodium hydrogen carbonate). By adding water, the acid dissolves on the surface, the sodium hydrogen carbonate starts a reaction, is fixed, and a granulate forms.

The technology is based on a surface modification of the citric acid applied in the effervescent mixture. The reactive citric acid is coated with an alkaline carbonate during the process and passivated. Sodium citrate develops on the acid surface . Depending on the duration of the granulation, about 20 to 30 percent of the citric acid converts into citrates during the reaction, so that the citric acid is coated with layers of citrates a few micrometers in thickness. The proportion of the converted citric acid transformed into citrate can be identified via infrared analytics, titration of the citric acid or semi quantitative determina­ tion of the carbon dioxide content after acidification.

Only a small amount of water which is needed for granulation is added during the our process. Additional water develops during the chain reaction from the conversion of citric acid with bi-carbonates or carbonates activated through moistening. To control and manage this chain reaction, a vacuum is applied repeatedly for certain periods of time during the granulation process to eliminate the reaction water. During this process step, the vacuum oscillates within the granulator between a maximum and a minimum value. The number of oscillating movements defines the reaction and the thickness of the moisture resistant surfaces This so-called “oscillating vacuum”

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