Tablet Compression: Compression – Consolidation - Compaction

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Tablet Compression: Compression – Consolidation - Compaction

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Tablet Compression Compression – Consolidation - Compaction:

Tablet Compression C o m p r e s s ion – C ons olida t i on - C o m pacti on By Vinod D Ramani Bhagwan Mahavir college of Pharmacy, Surat

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6 Tablets are made by compressing the formulation ingredientas containing the drugs along with the excipients on stamping machines. It is also called a press or simply compression machine. Tablets compression

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7

Slide8:

8 Basic Components of tablet press

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9

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10 Feed Frame

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11 Types of tablet press Comment !!

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12 Single Punch Machine Upper & Lower Collar Collar Locker

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14 Other Components of tablet press

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15 Factors affecting output of the tablet machine

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16 Compression Machine Tooling One tooling set consists of 2 punches and a die The two punches includes the upper and the lower punch. There are three types of tooling

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C L A SSI F I C A TI O N O F MU L T I - S TA T I O N P R ES S T OOLI N G TSM S T A N D ARD T SM is acron y m for the “ T ABLET SPE C I F I C A T ION M A NU AL”, w idely recogniz e d and e x clusi v e in the U nited States. T SM t oolin g s pe c i f i c a t i o n s ar e t h e s ol e ref eren c e o n U .S. m anufa c t u ring st andard s f o r t ablet s an d t able t t ooling. Est abli s he d b y t h e A m eri c a n Phar m a c i s t s Ass o c ia t io n (APhA). T SM t oolin g s pe c i f i c a t i o n s ar e t h e onl y publi s he d st andar d s f o r t h e t able t c o m pre s s io n indu str y . EU S T A N D A R D E U , is short for “E UR OS T A ND A RD ” consider e d as the European standa r d and also globally applicable. E U , m or e w idel y u s e d t ha n t h e T S M . E U , o r Euronorm st anda r d t oo l c on f igur a t ion s ar e no t publi s he d o r go v erne d b y an y organi z a t io n o r a ss o c ia t ion. T h e EU st andar d i s t h e m o st c o mm o n t oolin g c on f igura t i o n u s e d ou ts id e t h e U . S .

Basics of Tablet tooling:

Basics of Tablet tooling Tablet compression machines are made in keeping in view the type of dies and punches will be used on them, The dies and punches and their setup on compression machine is called tooling, it is classified as B and D mainly . The B tooling dies and punch can be further have specifications as BB D tooling can also be dies and punches can be utilised on B tooling machine which is called as DB

Types of Tooling available:

Types of Tooling available ‘B’ -Tooling ‘D’ – Tooling ‘BB’ -Tooling ‘DB’ – Tooling

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20 Types of tooling and specifications

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T OO L I N G T E R M I N O L OG I E S

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Head: The end of the punch that guides it through the cam track of tablet machine during Rotation. Head flat (Dwell Flat): The flat area of the head that receives the compression force from Rollers (in upper punches) and determines the weight and ejection height (in lower punches). Outside head Angle : The area gets in touch with the roller prior to head flat , while Compression. Inside Head Angle : This is the area, which pulls down the lower punches after ejection and lifts the upper punches after compression. Neck: The relived area between the head and barrel, which provides clearance for the cams. Barrel : This area guides the punch (while going up and down) with reference to turret guides. Stem: The area of the punch opposite the head, beginning at the tip and extending to the point where the full diameter of the barrel begins. If the chamfer is present the barrel usually reaches its full diameter just above the chamfer . Punch Terminology

Punch Terminology:

Punch Terminology Tip: This determines size, shape & profile Tip face : This area of punch is where the tablet is formed. Good surface finish is required here to get quality tablets. Working length : This distance between bottom of the cup and the head flat is called as working length which determines weight and thickness of the tablet. Overall length : Distance between top of the cup and the head flat. Key Angle : The relationship of the punch key to the tablet shape. The keys position is influenced by the tablet shape, take-off angle, and turret rotation. Domed Heads: Increases the dwell time and hence help to achieve the better tablet hardness. Dwell time – The time punches spends below the pressure roller while rotating in the machine. Clearance : Die bore dia – punch tip dia = Clearance. Hardness: Usually measured in HRC (Rockwell ‘C’ scale) and optimum readings are as follows: Punch Terminology

Die Terminology:

Die Terminology Die.O.D .: The outside diameter of the die, which is compatible with the die pockets in the press. Die Height : The overall height of the die. Die Bore : The cavity where the tablet is made. The Cavity’s shape and size determine the same form of tablet. Chamfe r: Entry angle of the die bore. Taper dies : dies with tapered bore on one or both sides. They are used for easy ejection of tablets (mainly for double layered tablets. Die Groove: The groove around the periphery of the die, which allows the die to be fixed in the press. Lined (Insert) Dies : Dies fitted with a linear insert made from a much harder, more wear resistant material such as tungsten carbide and ceramic . Die Terminology

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SHAPE S O F PUNCHES / T A BLE T I N REGULA R US E Rou nd G eometric C o nv e x C o nve x & Bevel O v a l Modi f ied O v a l C a ps ule Modi f ied C a ps ule C o mp oun d Cup F l a t F a ced F l a t F a ce d Be v el Edged F l a t F a ce d R a dius Edged De e p C o nc a ve (R o und/C a psule) Extra Deep Modi f ied B a ll Sh a l l o w C o nc a ve (R o und/C a psule) S t a n d a r d C o nc a ve (R o und/C a psule)

Slide26:

SHAPE S O F PUNCHES / T A BLE T I N REGULA R US E

Slide27:

SHAPE S O F PUNCHES / T A BLE T I N REGULA R US E

Type of Steel used for construction of die and Punches (hardened steel):

Type of Steel used for construction of die and Punches (hardened steel) STEEL        HARDNESS OHNS O1      58-59 HCHC D2      59-60 HCHC D3      61-62

TCM specification looks like:

TCM specification looks like

TCM Brands:

TCM Brands Cadmach Manesty Killian Korsch Sejong Ronchi

Advance Tooling Designs :

Advance Tooling Designs

Advance Tooling Designs :

Advance Tooling Designs

Stages of Tablet Compression:

Stages of Tablet Compression Filling Metering Compression Ejection

Stages of Tablet Compression:

Stages of Tablet Compression

Stages of Tablet Compression:

Stages of Tablet Compression FILLING T h e fil l i n g sta g e o f ta b l e t c o mpr e ss io n p r o c e ss i n v o lv e s tra n sfer o f g r anu l e s to the com p r e ss in g ma ch i n e p u nc h - d i e cav i t y . Th e p u nc h d i e cav ity i s com p os e d o f u p p e r p u nc h , d i e a n d l o w e r p u nc h . Th e p o siti o n o f l o w e r p u nch w ith i n the di e d e termi n e s the vol u me o f th e p u nch - d i e cav i t y . Th i s vo l um e must b e a p pr o pr i at e l y siz e d for t h e w e i g h t o f gr a n u l a tion to b e com p ress e d i nto ta b l ets. Th e gr a n u l a tion i s ov e rfil l e d o n t h e di e ta b l e (turret) to e n sure com p l ete fil l i n g o f th e p u nc h - d i e cav ity vo l um e .

Stages of Tablet Compression:

Stages of Tablet Compression MET E RING/W EIGHT A S D J U S TME N T The metering stage of the tablet compressing process involves removal of excess granulation from the compressing machine. This stage enables the exact weight (volume) of granulation to be compressed into tablets. The exact weight of granulation is controlled by the height of the lower punch in the die. The height of the lower punch is controlled by the metering cam (also called the dosage cam). The lower punch is raised to the appropriate level in the die to provide the exact weight of granulation in the punch-die cavity. The excess granulation is scraped from the surface of the die table.

Stages of Tablet Compression:

Stages of Tablet Compression COMP R E S SION The c ompre s si o n stage o f the tab l e t forms the tab l et. This stage i n v o lv e s bring i n g together the uppe r an d l o w e r pun c he s unde r pres s ur e w ithin the d ie to form the tab l et. As the pun c he s ente r the c ompre s si o n s tage, the uppe r an d l o w e r pun c he s mo v e bet w ee n t w o l arg e w hee l s c a ll e d pres s ure rol l s. These pres s ur e rol l s pu s h the pun c he s together to form the tab l et. T h e di s tance bet w ee n the uppe r an d lo w e r punche s dete r mi ne s the thi c k nes s an d the ha r dnes s o f the tablet. When the pun c he s ar e cl o se togethe r , a th i n an d har d tab l e t is created. W he n the pun c he s ar e farther apart , the tab l e t made is s ofter an d th i ck e r . The prope r ba l an c e o f thick ne s s an d hardne s s determ i ne s the opt i mum roll d istan c e for an y s pe cific produ ct. These ad j u stments ar e made w h ile k eep i n g the tab l e t w e i gh t c on s tant .

Stages of Tablet Compression:

Stages of Tablet Compression E J E C TION The eje c tion stage o f the tablet c o mp r essin g p r o c e s s invol v e s removal o f the tablet from the lo w e r pun c h - di e station. In this stage, the upp e r pun c h retra c ts from the di e c a v i ty an d ri s e s abov e the turret table. Then the lowe r pun ch ri s e s i n the die , whic h i n turn pus h e s the tab l e t up w ar d to the top s u rfa c e o f the di e t abl e an d ou t o f the di e c a v i t y . A scra pe r (a ls o c a lle d t a k eo f f s c ra pe r o r tablet rak e - o f f) then pu s he s the tablet o f f the die table a w a y from the c o mp r essin g ma c hin e int o the c o llectio n c o ntaine r through di sc h a r ging c h ute .

Post Compression Equipment :

Post Compression Equipment Tablet deduster or definger . This equipment removes excessive dust or fringes from the tablets by means of gentle agitation and vacuum. Metal detector This equipment detects metal fragments within the tablet. Tablet weight checker This equipment automatically weighs individual tablets and rejects out-of-specification tablet weights.

Physics Of Tablet Compression:

P h y s i c s O f T a bl e t C o m pre s s i o n C o m p r e s s ion C ons olida t i on C o m pacti on P r o ce ss of co m pre s s i o n F orce s involve d i n C o m p r e s s i on

Physics Of Tablet Compression:

P h y s i c s O f T a bl e t C o m pre s s i o n Co m p r ess i on C o m p r e s s i o n m ea n s a r e d u c t i on i n t h e b u l k vo l u m e of a m a t e r i a l a s a r es ul t of t h e r e m o val of the g a s e o u s p h a se ( a i r ) by a p pli e d p r e ss u r e . Con s oli da ti on C o ns oli d a ti o n i s a n i n c r e ase i n the m e ch a n i ca l s t r e n gt h of a m a t e r i a l r es ul t i ng fr om p a r ti c l e - pa r ti c l e i n t e r a c t i o n s . Co m p ac t i on C o m p ac ti o n o f p o w d e r s i s the g e n e r al t e r m u se d t o d e s c ri be t h e s it u a ti o n i n whi c h t h e se m a t e r i a l s a r e s u bj e c t e d t o s o m e l e vel of m e ch a n i ca l f o r c e . T h e ph y s i c s o f co m pa c ti o n m a y be s i m p l y s t a t e d a s "t h e c o m pr e ss i o n a nd c o n s o li d a ti o n of a t w o - pha se ( p a rt i c u l a t e s ol i d - ga s ) s y s t em due t o the a p pl i e d fo r c e . "

Physics Of Tablet Compression:

P h y s i c s O f T a bl e t C o m pre s s i o n

Consolidation:

C o n s oli da t i on A n in c r ea se i n the m ec h a ni c a l s t r e n gt h of the m a t e r i a l r es ul t i ng fr om p a r ti c l e o r p a rt i c l e in t e r a c ti o n. (I nc r ea s i ng i n m ec hani ca l s t r e n g t h of the m a s s) C on s o l i d a t i o n P ro c es s C o l d w e l d i n g : Whe n t h e s u rf a ce of t w o p a rt i c l e s a p p r oa c h e a c h o th e r c l os e l y e n o u g h, ( e .g. a t s e p a r a ti on of l e s s th a n 50 n m ) t h e i r f r e e s u rf ac e e n e r gi e s r e s ul t i n s t r o ng a tt r ac t ive fo r c e , th i s p r oc e s s k nown a s c ol d w e l di n g . F u s i on bon di ng: C o n t ac t s o f p a rt i c l e s at m u lti p l e p o in t s u pon a pp l i ca t i on of l o a d , p r o d u c e s h e at whi c h ca u s e s f u s i on o r m e l ti n g . I f t h i s he a t i s not di s s ipat e d, t h e l o ca l r i s e i n t e m p e r a t ur e c o u l d be s uf f i c i ent t o ca u se m e l ti ng of t he con t ac t a r e a o f t he p a r ti c l e s . U p o n r e m o v a l o f lo a d i t g e t s s o li d i f i e d gi v i ng r i se t o f u s i o n b o nd i ng & in c r ea se the m ec h a n i ca l s t r e n g t h of m a s s .

Slide45:

. T he pr o c e s s of c o m pr e ss i o n. RE MOVA L O F P RE SS U R E

Slide46:

T r a ns i t i on a l r e p ac k i n g / p ar t i cle r ea rr a n g e m e n t .

Slide47:

D e f o r m a ti on • T he f o r ce r equi r e d t o i niti a t e a pl a s ti c d e f o r m a t i on i s c a ll e d a s y i e l d s tr e s s or e l a s t i c li m it .

Slide49:

F r a gm e n t a t i on and def o r m a t i o n . F r a g m entati on do not o cc ur w he n applie d s tre s s - i s b a lan c e d by a pl as ti c d e f o r m a t i on. c hange i n s hap e . s li d i ng o f grou p s o f p a r ti c l e ( v i s c oel a s t i c fl o w ) .

Slide50:

A f t er f r ag m e n t a ti o n o f the p art i c l es, a s t he p r e s s ur e i n cr e as e s , f o r m a ti o n o f n e w bon ds b e t w een t h e p a r ti c l es at t h e c o n t a ct ar e a o c c u r s . T h e h y p o t h es i s f a v o u r i ng f o r the i n c r e as i n g m echa n i cal s t r e ng t h of a b ed o f po w d er w h en s ub jec t ed t o r i s i n g c o m pressi ve f o r c es c a n be e xp l a i n ed b y t h e f o ll o w i ng t h e o ry. Bo nd i n g Mec h an i sm The r e are t h r ee t h e o r i es a b o ut t h e bond i n g o f p ar ti c l es i n t h e t a b l et by c o m pression Mec h a n i cal t h e o ry I n t er m ol e c u l ar f o r ce t h eo ry L i qu i d - F i lm s u rf a c e t h eo ry B o n d i n g O f P a r t i cle s

Slide51:

T h e m ech a n i c a l t h e o ry I t o ccur s b e t w een i rr e g u l ar l y s h a p e d pa r t i c l e s . The m ec h ani c al t h eor y pr opo s es t h a t , un de r p r e s s ur e t h e i nd i v i du a l p ar ti c l e s und e r g o E l as ti c / P l as ti c d ef o r m a t i on and t he p a r t i c l e bou n d ar i es t hat t h e e dg e s o f t h e p ar t i c le int e r m esh f o r m i n g a m echa n i cal B o nd . M e cha n i cal in t e r l o c k i n g i s no t a m aj o r m ec h a n i s m o f b ond i n g i n p h ar m a c e u ti cal t a b l e t i n g . B o n d i n g O f P a r t i cle s

Slide52:

T h e M o l ec u l e s a t t h e su rf a c e o f s o li d s h a ve u n s a t i s f i e d f o r ce s whi c h i n t e r a ct wi t h the othe r pa r ti c l e i n t r u e c o nt a c t . Ac c o r d i ng t o t hi s t h e o r y , un d e r c o m p r ess i o n a l p r e s su r e the m ol e cul e s a t t h e p o in t s of t r u e c o nt a ct bet w e e n ne w c l e a n s ur f ace s of t h e gr a n u l e s a r e c l o se e n o u gh so t h a t v a n d e r w aa l s fo r c e s i nt e r ac t t o c o n s o lidat e the pa r ti c l e s . M a t e ri a l c o n t a i n i ng pl e n t y O H g r o up m a y a l s o c r e a t e h y d r o g e n b ond bet w e e n m o l ec u l e s . E .g. m i c r o c r y s t a l l ine c e ll u l o se i s b e l i e ve d t o u nde r go s i g ni f i ca n t h y dr oge n b o n di ng d u r i n g tabl e t c o m p r e s s i on T h e i nt e r m ol e c ul a r f o r ce s t h e o r y a n d t he l iqu i d - su rf a ce f i l m t h e o r y a r e beli e v e d t o b e t h e m a j or b o n di n g m e c h a n i s m s i n t a b l e t c o m pr e ss i o n In t e r mo l e cu lar f o rc e the o r y

Ejection.:

E j ec t i on . P o r ti o n u nde r s tr a i n ca ps s t r a i n > s h e a r s t r e ng t h.

3 stages of force necessary to eject a finished table:

3 s t a g e s of f or c e n e ce ss a r y t o e j e c t a f i n i she d t a b l e P e a k fo r c e r e q ui r e d t o i n iti a t e e j ec ti o n. S m a l l fo r ce r e q ui r e d t o p u s h t a b l e t u p t o d i e - w a l l . De c line f o r ce a s t a b l e t e m e r g e fr o m d i e .

Slide55:

V a r i ous F o r c e s in v ol v e d i n C o mpr e ss ion F r i c t i o n a l F o r ce s D i s t r i b uti o n F o r c e s R a d i a l F o r ce s E j e c ti o n Fo r c e s  Fri c ti o n a l F or ce s: a r e i nt e r p a rt i c u l a t e fr i c t i on & Di e w a l l F r i c ti o n . r e d u ce d G l idant s E . g . Col l oi dal s i l i c a L u b ri ca n t s E.g. Ma g. St ea r a t e  D i s t r i b uti o n F o r c e s: M o st i n v e s t ig a t i o n a l o f f u n d a m e n t a l o f tabl e t i ng h a v e b ee n ca rri e d o ut on s i n g l e p u n c h p r e s s e s wi t h h y d r a u li c Pr e s s . Ej e c ti o n Fo r c e s: R a d i a l d i e w a l l fo r ce s & d i e w a l l fr i c ti on a l so a f f ec t s e j e c ti o n o f t h e c o m p r e s s e d t a b l e t f r om di e . T he f or c e n ece ssa r y t o e j ec t a f ini s h e d t a b l e t i s k n o w n a s Ej e c ti o n Fo r ce . Va r i a ti o n a l s o o c c u r s i n e j e c ti o n f o r c e w he n l u b ri ca ti o n i s i n a d e q u a t e . 

Measurement of compression forces:

Measurement of compression forces Strain gauge

Measurement of compression forces:

Measurement of compression forces Strain gauge

Measurement of compression forces:

Measurement of compression forces Piezo – Electric Cell

Measurement of compression forces:

Measurement of compression forces Piezo – Electric Cell

Heckal’s plot:

Heckal’s plot The heckel analysis is a most popular method of determining the volume reduction under the compression pressure in pharmacy. Powder packing with increasing compression load is normally attributed to particle rearrangement, elastic and plastic deformation and particle fragmentation. Heckel analysis is based on the assumption that powder bed densification follows first order kinetics .

Heckal’s plot:

Heckal’s plot In heckel equation the decrease in porosity of powder bed as the compression force increases is assumed to follow the following equation: Where, D= ρ ave / ρ true ρ ave = the average density of the powder bed. ρ true = true density of the powder. (1-D) = porosity. K = constant. Upon integration: In heckel plot we draw ln[1/1-D] as a function of compression pressure P.

Types of Heckal’s plot:

Types of Heckal’s plot Type A Heckel plot: For plastic deforming bodies. It is possible to distinguish the three different types of powder behavior by compressing different size fraction of the same material. For plastically deforming materials the Heckel plots, drawn from different size fractions remain parallel over the entire pressure range. Examples: MCC, Starch

Types of Heckal’s plot:

Types of Heckal’s plot Type B Heckel plot : For fragmenting materials. For fragmenting materials, the plots become coincidental as the compression pressure increases. Examples: Lactose, Sucrose.

Types of Heckal’s plot:

Types of Heckal’s plot Type C Heckel plots : After initial linear part the plots become coincidental because the material packing fraction approaches unity at quite low compressive stress level. Examples: Fatty acids or Lactose mixed with high percentage of fatty acids.

Heckal’s plot:

Heckal’s plot Significance of Heckel Plots : The Heckel constant k, has been related to the reciprocal of the mean yield pressure, which is the minimum pressure required to cause deformation of the material under compression. The intercept of the curve portion of the curve at low pressure represents a value due to densification by particle rearrangement. The intercept obtained from the slope of the upper portion of the curve is a reflection of the densification after consolidation. A large value of the Heckel constant indicates the onset of plastic deformation at relatively low pressure. A Heckel plot permits an interpretation of the mechanism of bonding

Heckal’s plot:

Heckal’s plot Weakness of Heckel Plots : Shape of the plot is very sensitive for small errors in the determination of powder true density. Linear part of the plot is sometimes difficult to determine. Heckel plot determination need very accurate data. Even the deformation of the tablet compression machine has to be recorded.

Slide67:

R e f e r e n c e s : -  K e i t h m a r sh a ll 1 98 7, C o m pr e s si o n a n d c on s o l i d a t i o n of p o w d e rd s o l i d s, L e o n l a c h m a n , H e r b e rt a . Li b e r m a n, & Jose p h k a ni g , T h e th e ory and p r a c ti c e of in d u s trial p h a r m a c y , thi rd e diti on v a r g h es e p u b l i c a ti o n h o u s e ,b o m b a y , p p . 6 6,6 8 ,7 0 -8 8 . E u g e n e p a rrott , 2 00 7, C o m pr e ssi on , H e rb e rt A . Lib e r m a n, L e o n L a c h m a n & Jos e ph B . Sc h w a rtz , P h a r m a c e ut i c a l d o sa g e for m s , t a b l e t s , v olu m e i i , p p. 2 0 1 - 24 1. St a nfort h J . N , Aul t o n ’s pharm a c e uti c s the d e si g n and m an ufa c tu ri ng o f m e di c in e , t h ir d e d it i o n, C hu r c hill l i v i n g st o ne e l se v i e r, p p.1 76 , 17 7. S ub r a h m a nya m C . V . , M i c r o m e r i ti c s , T e xt b o ok O f P h y si c al P ha rma c e uti c s , S e c o nd E d it i on , v a l l a b h pr a k a s h a n, d e l h i , Pp-1 80 - 2 3 4 . Gilb e rt S . B a n k e r , C h ri s t o p h e r T . R h o d es , M o d e r n P ha rma c e uti c s , F o urt h E d iti o n .Pp . 40 8-4 0 9. www . g o o gl e . c o m     

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