Everything You Know About Tablets & Capsules Is Wrong
Among the popular oral dosage form, the tablet and capsule are two of them. There is a reason for a person to understand the tablet manufacturing process. The tablet manufacturing process knowledge is vital for students studying pharmacy, tablet press manufacturers, medical practitioners, or physicians, among other professions. The manufacture and design of pharmaceutical tablets is a multi-stage complex process whereby the formulation scientists ensure that the drug substance’s correct amount is delivered at the appropriate time in the proper form. Also, in the desired location and reasonable rate along with its protected chemical integrity to that point. Generally, most drug substances fail to possess the needed properties, which offer good flow, usually from the hopper to the tablet presses die cavity. Thus they are subjected to pre-treatment either in combination or alone along with suitable excipients for free-flowing granules formation that lends themselves to tableting. Just like the tablet manufacturer in India, several others can be found across the globe.
Manufacturing machines
As there is a range of tablets available in the market, one must expect distinctive machine types. The reason is distinctive tablets need distinctive manufacturing processes and formulations. Standard machines that be used in pharmaceutical tablets manufacturing comprise:
Tablet compression machine- This machine assists the company in the ingredients compression for forming a tablet. The single punch tablet press is usually identified as the eccentric or single station press. Such a machine employs one station tooling set comprising a die and a pair of upper and lower punches. The compaction force on such fill materials comes chiefly from the upper punch. Meanwhile, the lower punch has to remain static. A person can liken it to a single hammer punch, resulting in the name stamping process. There is a capability of a machine for producing the tablets in between 60 and 85 minutes.
Dry granulation equipment- The dry granulation is processed while granule formulation fails to need any liquids. The dry granule’s formulation will need dry powder’s densification for agglomeration. The dry granulation machine is chiefly up to the specific factors producing the particles of the correct size. Several other factors are roll design, die diameter, roller speed, feed rate, tooling features, and particle size. This machine has sub-classes that a person can distinguish through the densification application mechanism’s force. The subclasses can be described as slugging and roller compactor.
Wet granulation equipment- The wet granulation offers the mixing homogeneity of the drug’s distribution in the blend. Such process sensitivity needs a person to have equipment of suitable wet granulation.
Mixing equipment- One night, identify pneumatic mixers like air or air drive mixers. The mixer uses air compression or air bubbles instead of electricity chiefly for homogenizing or mixing or mixing powders. It has a central conveying tube and mixing silo for mixing and spreading the materials. Also, it has a housing gone along the aerators around it. Through nozzles, the compressed air passes into the silo. The active pharmaceutical ingredients are being mixed in it, particularly those along with the expansion characteristics.
Size reduction equipment- When a person is manufacturing a compressed tablet, the process becomes more straightforward when there is a specific size for the particles. It offers a more and greater uniform dosage. There is an actual fine particle size in cases of lubricant mixing along with the granules for proper functions, generally, apart from improving the API or medication’s biological availability. A range of equipment is used for sizing, comprising the ball mill, colloidal mill, and fluid energy mill. The conical mill, cutting mill, roller mill, and hammer mill are others.
Drying equipment- The fluidized bed dryer is one of the pieces of equipment extensively used for moisture content in a tablet. It is up to the principle of feed material’s fluidization. The process comprises the hot air introduction at very high temperatures by the most tablet’s perforated beds. With air passes, it suspends and lifts the wet tablets. Between the wet tablets and hot gasses, a direct contact results in a heat transfer. It carries away the liquid in the process from the tablets resulting in it being dry.
Pharmaceutical instruments- Also, tablet manufacturing needs some time to be spent in the lab. Therefore, for that purpose, there is a requirement for pharmaceutical purposes. The instances for pharmaceutical instruments are friability testers, power handling equipment, tablet hardness testers, tablet testing equipment, dissolution testers, freeze dryers, melting point apparatus, Karl Fischer machines, and photoelectric flame photometers and thermometers.
One can use such machines for specific purposes like the active pharmaceutical ingredients measurement.
Steps for tablet formulation
Dispensing- Each ingredient present in the tablet formula is accurately dispensed and weighed as per dose. In any formulation process, this is one of the critical steps and must be done under technical supervision.
Sizing- The formulation ingredients should be in finely divided form. Or, in another case, the size reduction is carried out for better easy mixing and flow properties.
Power blending- With suitable blender usage, the powders are mixed to obtain a homogeneous and uniform powder mix. The excipients and drug substances are mixed chiefly in a geometric dilution.
Granulation- In this, gathering together of small powder particles is done into layers and permanent aggregating for rendering them into the state as free-flowing.
Drying and dry screening- The screened wet granules must be dried for a specific period in a fluid bed dryer and tray dryer at a controlled temperature that fails to exceed 550C. With the help of an appropriate mesh screen, the dried granules are screened.
Tablet compression- In this step, the granules compression is done into a convex or flat, oblong, round or unique shaped, unscored or scored tablets and generally engraved along an identifying code number and symbol with the usage of a tablet press.
Coating- The granules and tablets are coated in case there is a need to mask the unpleasant odor/ taste of some drug substance or boost the uncoated tablet’s aesthetic appeal, also for the modification of release or control of the drug substance’s release from tablets. It can be achieved by covering or enclosing the core granules or tablets and coating solutions.
Storing and packaging of tablets
Before tablets are distributed, they are packaged with the help of appropriate packaging material. The packaging material kind used is a choice and up to several factors.
Usually, the tablets are packaged using strip packs and blisters, kept in low humidity places, and protected from extremes in temperature. The packaging offers excellent environmental protection for each tablet unit and an aesthetically efficacious and pleasing appearance. Such packaging also offers some tamper resistance degree to the dosage form. Metal containers, paperboard drums, plastic or glass bottles, or cartons might be used along with polyethylene liners for larger quantities delivered to the pharmacist. In case the stuffing of cotton wool is being used under such circumstances, then it is a benefit for the liners to be external, and thus, any moisture that it comprises failed to gain access to the tablets. When exposed to moisture, the decomposed can also be packaged with the desiccant packet. In containers of light resistance, the light-sensitive tablets are being packed.
Quality control tests
Before a company starts marketing the tablets, there is a need to be sure that for human usage, they are fit. One has to subject the tablets with the help of a test series before even releasing them to the public. The tablets are required to conform to the pharmaceutical industry’s official compendium and conventional needs. There are mainly two categories in which the series of tests fall:
Non–official test or non-pharmacopoeial- These are the tests being performed on the tablets even though they failed to be on the official compendia. It chiefly concerns a range of quality attributes that one has to evaluate, comprising thickness test, the table’s porosity, tensile strength’s determination, hardness strength, or crushing strength. Most of such tests failed to have an official testing limit mainly for acceptance and might vary from manufacturer to manufacturer. In some cases, it varies depending on the formulation. The crushing strength limit, even though it was on the British Pharmacopoeia, failed to set any limit. Therefore, it will remain under the tests as non-official. The pharmaceutical tablet’s quality tests need one to be keen extremely. A defect may result in detrimental effects mainly to the final consumer.
Official test or pharmacopoeial- The tests are considered official as the testing procedure is in the official compendia comprising the American pharmacopeia and British Pharmacopoeia. Usually, these are standard testing procedures with clear limitations dictating the tablet’s levels reached. The quality tests comprise uniformity of the tablet’s weight, testing for the tablet’s dissolution, testing for the tablet’s disintegration time, and testing the active ingredient or the drug’s unlimited content. Such tests aim in vitro release or ok the content of the active ingredients. One must ensure that the ingredient list’s present content matches the tablet’s content. Apart from that, the tablet’s content should conform to all the official test requirements.
Excipients usage
In addition to the therapeutic agents, the tablets comprise excipients needed to ensure the process as satisfactory production. Such inert materials might be added to the drug substance to increase its bulk and offer those desirable properties chiefly lacked alone in the drug substance.
Several excipients usage in tablet formulation are just multi-functional then they might serve more than one function. Thus they can affect the tablets or powder’s properties at varying concentrations.
Generally, all excipients usage in tablet formulation might fail to be present in all tablet formulas. Several like microcrystalline cellulose, stearates, and lactose are usual for the tablet’s vast majority. The excipients usage in tablet formulations comprises granulating or binders fluid, lubricants, colorants, diluents, glidants, disintegrants, flavourants, surfactants, sweeteners, and absorbents.
Factors affecting the formulation process
Physical and chemical stability of the API- Formulation processes might alter and affect the chemical and physical stability chiefly of the active pharmaceutical ingredient. Therefore, a person should be careful when selecting the formulation process. Thus be sure that the active pharmaceutical ingredient’s integrity is failed to be lost in the formulation process.
Processing equipment’s availability- While choosing a process of formulation, then be sure that there is necessary processing equipment available. A person might decide on the formulation process while the machine present might fail to be compatible.
Drug substance compression or API properties- Active pharmaceutical ingredients or drug substances have distinctive compression properties. A person might prefer a formulation process that failed to go well along with the active ingredients. One might have performed prior research on the active ingredients and their compatibility for unique formulation processes.
Particle’s size of the formulation ingredients- There is a need to look at the active pharmaceutical ingredient size before choosing the formulation process. Meanwhile, specific formulation processes can accommodate particular particle sizes only. The formulation might need more extensive or tiny particles, mainly for active formulation.
Cost of the manufacturing or formulation process- The budget plays a huge role in the formulation process one intends to use. A low budget might fail to afford the efficient formulation process’s luxury. A person might have to ensure that all the necessary funds are for a specific formulation process.
Conclusion
It can be concluded that pharma capsule manufacturers usually manufacture them using direct compression, dry granulation, and wet granulation. They chiefly vary in hardness, weight, shape, disintegration, dissolution, and thickness and share characteristics among other chief aspects.
Manufacturing machines
As there is a range of tablets available in the market, one must expect distinctive machine types. The reason is distinctive tablets need distinctive manufacturing processes and formulations. Standard machines that be used in pharmaceutical tablets manufacturing comprise:
Tablet compression machine- This machine assists the company in the ingredients compression for forming a tablet. The single punch tablet press is usually identified as the eccentric or single station press. Such a machine employs one station tooling set comprising a die and a pair of upper and lower punches. The compaction force on such fill materials comes chiefly from the upper punch. Meanwhile, the lower punch has to remain static. A person can liken it to a single hammer punch, resulting in the name stamping process. There is a capability of a machine for producing the tablets in between 60 and 85 minutes.
Dry granulation equipment- The dry granulation is processed while granule formulation fails to need any liquids. The dry granule’s formulation will need dry powder’s densification for agglomeration. The dry granulation machine is chiefly up to the specific factors producing the particles of the correct size. Several other factors are roll design, die diameter, roller speed, feed rate, tooling features, and particle size. This machine has sub-classes that a person can distinguish through the densification application mechanism’s force. The subclasses can be described as slugging and roller compactor.
Wet granulation equipment- The wet granulation offers the mixing homogeneity of the drug’s distribution in the blend. Such process sensitivity needs a person to have equipment of suitable wet granulation.
Mixing equipment- One night, identify pneumatic mixers like air or air drive mixers. The mixer uses air compression or air bubbles instead of electricity chiefly for homogenizing or mixing or mixing powders. It has a central conveying tube and mixing silo for mixing and spreading the materials. Also, it has a housing gone along the aerators around it. Through nozzles, the compressed air passes into the silo. The active pharmaceutical ingredients are being mixed in it, particularly those along with the expansion characteristics.
Size reduction equipment- When a person is manufacturing a compressed tablet, the process becomes more straightforward when there is a specific size for the particles. It offers a more and greater uniform dosage. There is an actual fine particle size in cases of lubricant mixing along with the granules for proper functions, generally, apart from improving the API or medication’s biological availability. A range of equipment is used for sizing, comprising the ball mill, colloidal mill, and fluid energy mill. The conical mill, cutting mill, roller mill, and hammer mill are others.
Drying equipment- The fluidized bed dryer is one of the pieces of equipment extensively used for moisture content in a tablet. It is up to the principle of feed material’s fluidization. The process comprises the hot air introduction at very high temperatures by the most tablet’s perforated beds. With air passes, it suspends and lifts the wet tablets. Between the wet tablets and hot gasses, a direct contact results in a heat transfer. It carries away the liquid in the process from the tablets resulting in it being dry.
Pharmaceutical instruments- Also, tablet manufacturing needs some time to be spent in the lab. Therefore, for that purpose, there is a requirement for pharmaceutical purposes. The instances for pharmaceutical instruments are friability testers, power handling equipment, tablet hardness testers, tablet testing equipment, dissolution testers, freeze dryers, melting point apparatus, Karl Fischer machines, and photoelectric flame photometers and thermometers.
One can use such machines for specific purposes like the active pharmaceutical ingredients measurement.
Steps for tablet formulation
Dispensing- Each ingredient present in the tablet formula is accurately dispensed and weighed as per dose. In any formulation process, this is one of the critical steps and must be done under technical supervision.
Sizing- The formulation ingredients should be in finely divided form. Or, in another case, the size reduction is carried out for better easy mixing and flow properties.
Power blending- With suitable blender usage, the powders are mixed to obtain a homogeneous and uniform powder mix. The excipients and drug substances are mixed chiefly in a geometric dilution.
Granulation- In this, gathering together of small powder particles is done into layers and permanent aggregating for rendering them into the state as free-flowing.
Drying and dry screening- The screened wet granules must be dried for a specific period in a fluid bed dryer and tray dryer at a controlled temperature that fails to exceed 550C. With the help of an appropriate mesh screen, the dried granules are screened.
Tablet compression- In this step, the granules compression is done into a convex or flat, oblong, round or unique shaped, unscored or scored tablets and generally engraved along an identifying code number and symbol with the usage of a tablet press.
Coating- The granules and tablets are coated in case there is a need to mask the unpleasant odor/ taste of some drug substance or boost the uncoated tablet’s aesthetic appeal, also for the modification of release or control of the drug substance’s release from tablets. It can be achieved by covering or enclosing the core granules or tablets and coating solutions.
Storing and packaging of tablets
Before tablets are distributed, they are packaged with the help of appropriate packaging material. The packaging material kind used is a choice and up to several factors.
Usually, the tablets are packaged using strip packs and blisters, kept in low humidity places, and protected from extremes in temperature. The packaging offers excellent environmental protection for each tablet unit and an aesthetically efficacious and pleasing appearance. Such packaging also offers some tamper resistance degree to the dosage form. Metal containers, paperboard drums, plastic or glass bottles, or cartons might be used along with polyethylene liners for larger quantities delivered to the pharmacist. In case the stuffing of cotton wool is being used under such circumstances, then it is a benefit for the liners to be external, and thus, any moisture that it comprises failed to gain access to the tablets. When exposed to moisture, the decomposed can also be packaged with the desiccant packet. In containers of light resistance, the light-sensitive tablets are being packed.
Quality control tests
Before a company starts marketing the tablets, there is a need to be sure that for human usage, they are fit. One has to subject the tablets with the help of a test series before even releasing them to the public. The tablets are required to conform to the pharmaceutical industry’s official compendium and conventional needs. There are mainly two categories in which the series of tests fall:
Non–official test or non-pharmacopoeial- These are the tests being performed on the tablets even though they failed to be on the official compendia. It chiefly concerns a range of quality attributes that one has to evaluate, comprising thickness test, the table’s porosity, tensile strength’s determination, hardness strength, or crushing strength. Most of such tests failed to have an official testing limit mainly for acceptance and might vary from manufacturer to manufacturer. In some cases, it varies depending on the formulation. The crushing strength limit, even though it was on the British Pharmacopoeia, failed to set any limit. Therefore, it will remain under the tests as non-official. The pharmaceutical tablet’s quality tests need one to be keen extremely. A defect may result in detrimental effects mainly to the final consumer.
Official test or pharmacopoeial- The tests are considered official as the testing procedure is in the official compendia comprising the American pharmacopeia and British Pharmacopoeia. Usually, these are standard testing procedures with clear limitations dictating the tablet’s levels reached. The quality tests comprise uniformity of the tablet’s weight, testing for the tablet’s dissolution, testing for the tablet’s disintegration time, and testing the active ingredient or the drug’s unlimited content. Such tests aim in vitro release or ok the content of the active ingredients. One must ensure that the ingredient list’s present content matches the tablet’s content. Apart from that, the tablet’s content should conform to all the official test requirements.
Excipients usage
In addition to the therapeutic agents, the tablets comprise excipients needed to ensure the process as satisfactory production. Such inert materials might be added to the drug substance to increase its bulk and offer those desirable properties chiefly lacked alone in the drug substance.
Several excipients usage in tablet formulation are just multi-functional then they might serve more than one function. Thus they can affect the tablets or powder’s properties at varying concentrations.
Generally, all excipients usage in tablet formulation might fail to be present in all tablet formulas. Several like microcrystalline cellulose, stearates, and lactose are usual for the tablet’s vast majority. The excipients usage in tablet formulations comprises granulating or binders fluid, lubricants, colorants, diluents, glidants, disintegrants, flavourants, surfactants, sweeteners, and absorbents.
Factors affecting the formulation process
Physical and chemical stability of the API- Formulation processes might alter and affect the chemical and physical stability chiefly of the active pharmaceutical ingredient. Therefore, a person should be careful when selecting the formulation process. Thus be sure that the active pharmaceutical ingredient’s integrity is failed to be lost in the formulation process.
Processing equipment’s availability- While choosing a process of formulation, then be sure that there is necessary processing equipment available. A person might decide on the formulation process while the machine present might fail to be compatible.
Drug substance compression or API properties- Active pharmaceutical ingredients or drug substances have distinctive compression properties. A person might prefer a formulation process that failed to go well along with the active ingredients. One might have performed prior research on the active ingredients and their compatibility for unique formulation processes.
Particle’s size of the formulation ingredients- There is a need to look at the active pharmaceutical ingredient size before choosing the formulation process. Meanwhile, specific formulation processes can accommodate particular particle sizes only. The formulation might need more extensive or tiny particles, mainly for active formulation.
Cost of the manufacturing or formulation process- The budget plays a huge role in the formulation process one intends to use. A low budget might fail to afford the efficient formulation process’s luxury. A person might have to ensure that all the necessary funds are for a specific formulation process.
Conclusion
It can be concluded that pharma capsule manufacturers usually manufacture them using direct compression, dry granulation, and wet granulation. They chiefly vary in hardness, weight, shape, disintegration, dissolution, and thickness and share characteristics among other chief aspects.
Leave a Reply