US 7,634,390 B2 · Pan coating simulation for determining tablet coating uniformity

A method for simulating a pan coating process to estimate at least one of tablet coating uniformity or coated tablet weight uniformity for a plurality of tablets, the pan coating process cycling the plurality of tablets within a tablet bed In a pan, the method comprising the steps of:

(i) obtaining a plurality of parameters associated with the pan coating process, the plurality of parameters including a tablet path distribution corresponding to the tablet bed in the pan;
(ii) randomly selecting, via a Monte Carlo simulation method, a tablet path for each cycle of a simulation tablet within the tablet bed;
(iii) calculating a coating amount for at least one cycle of the simulation tablet based on the selected tablet path;
and
(iv) summing the calculated coating amounts for the at least one cycle of the simulation tablet:
to produce a tablet coating weight;
(v) repeating steps (ii)-(iv) for each of a defined number Of simulation tablets representing the plurality of tablets;
(vi) determining at least one of tablet coating uniformity or coated tablet weight uniformity for the plurality of tablets based at least in part on the tablet coating weight for each of the simulation tablets;
and
(vii) setting operating conditions of pan coating equipment based on the plurality of parameters and at least one of the determined tablet coating uniformity or the determined coated tablet weight uniformity for the plurality of tablets;
wherein the pan has a shape including at least one cylindrical portion and at least one non-cylindrical portion and the tablet bed has an associated shape corresponding to the shape of the pan and wherein the tablet path distribution is a volume based distribution corresponding to the associated shape of the tablet bed.

8 more elements

A method for simulating a pan coating process to estimate at least one of tablet coating uniformity or coated tablet weight uniformity for a plurality of tablets, the pan coating process cycling the plurality of tablets within a tablet bed in a pan, the method comprising the steps of:

(i) obtaining a plurality of parameters associated with the pan coating process, the plurality of parameters including a tablet path distribution corresponding to the tablet bed in the pan;
(ii) randomly selecting, via a Monte Carlo simulation method, a tablet path for each cycle of a simulation tablet within the tablet bed;
(iii) calculating a coating amount for at least one cycle of the simulation tablet based on the selected tablet path;
and
(iv) summing the calculated coating amounts for the at least one cycle of the simulation tablet to produce a tablet coating weight;
(v) repeating steps (ii)-(iv) for each of a defined number of simulation tablets representing the plurality of tablets;
(vi) determining at least one of tablet coating uniformity or coated tablet weight uniformity for the plurality of tablets based at least in part on the tablet coating weight for each of the simulation tablets;
and
(vii) setting operating conditions of pan coating equipment based on the plurality of parameters and at least one of the determined tablet coating uniformity or the determined coated tablet weight uniformity for the plurality of tablets;
wherein the plurality of parameters further includes a tablet bypass distribution for bypassing a simulation spray zone associated with the tablet bed in the pan and wherein the calculating step comprises the steps of:
(iiiA) randomly selecting whether the simulation tablet passes through the simulation spray zone or bypasses the simulation spray zone in accordance with the tablet bypass distribution for each cycle of the tablet:
and
(iiiB) calculating a coating amount for each cycle of the simulation tablet passing through the simulation spray zone, wherein a coating amount is not calculated for each cycle of the simulation tablet that bypasses the simulation spray zone.

10 more elements

A method for simulating a pan coating process to estimate at least one of tablet coating uniformity or coated tablet weight uniformity for a plurality of tablets, the pan coating process cycling the plurality of tablets within a tablet bed in a pan, the method comprising the steps of:

(i) obtaining a plurality of parameters associated with the pan coating process, the plurality of parameters including a tablet path distribution corresponding to the tablet bed In the pan;
(ii) randomly selecting, via a Monte Carlo simulation method, a tablet path for each cycle of a simulation tablet within the tablet bed;
(iii) calculating a coating amount for at least one cycle of the simulation tablet based on the selected tablet path;
and
(iv) summing the calculated coating amounts for the at least one cycle of the simulation tablet to produce a tablet coating weight;
(v) repeating steps (ii)-(iv) for each of a defined number of simulation tablets representing the plurality of tablets;
(vi) determining at least one of tablet coating uniformity or coated tablet weight uniformity for the plurality of tablets based at least in part on the tablet coating weight for each of the simulation tablets;
and
(vii) setting operating conditions of pan coating equipment based on the plurality of parameters and at least one of the determined tablet coating uniformity or the determined coated tablet weight uniformity for the plurality of tablets;
wherein the step of calculating a coating amount is based on a slip factor corresponding to a rotational movement of the tablet bed relative to the pan.

7 more elements

A method for simulating a pan coating process to estimate at least one of tablet coating uniformity or coated tablet weight uniformity for a plurality of tablets, the pan coating process cycling the plurality of tablets within a tablet bed In a pan, the method comprising the steps of:

(i) obtaining a plurality of parameters associated with the pan coating process, the plurality of parameters including a desired coating time, a cycle time distribution, and a tablet bypass distribution for bypassing a simulation spray zone associated with the tablet bed;
(ii) randomly assigning via a Monte Carlo simulation method, a cycle time for each cycle of a simulation tablet;
(iii) summing the cycle times assigned to each cycle;
(iv) randomly selecting whether the simulation tablet passes through the simulation spray zone or bypasses the simulation spray zone in accordance with the tablet bypass distribution for each cycle of the simulation tablet;
(v) calculating a cycle coating amount only for cycles of the simulation tablet passing through the simulation spray zone;
(vi) repeating steps (ii)-(v) until a sum of the cycle times from step (iii) is greater than or equal to the desired coating time to identify a number of cycles for the simulation tablet;
(vii) determining a tablet coating weight for the simulation tablet based on the number of cycles and the cycle coating amounts;
(viii) repeating steps:
(ii)-(vii) far each of a defined number of simulation tablets representing the plurality of tablets;
(ix) determining at least one of tablet coating uniformity or coated tablet weight uniformity for the plurality of tablets based at least in part on the tablet coating weight for each of the simulation tablets;
and
(x) setting operating conditions of pan coating equipment based on the plurality of parameters and at least one of the determined tablet coating uniformity or the determined coated tablet weight uniformity for the plurality of tablets.

9 more elements

A magnetic disk, optical disk or memory card, including software that is configured to control a computer to implement a method for simulating a pan coating process to estimate at least one of tablet coating uniformity or coated tablet weight uniformity for a plurality of tablets, the pan coating process cycling the plurality of tablets within a tablet bed in a pan, the method comprising the steps of:

(i) obtaining a plurality of parameters associated with the pan coating process, the plurality of parameters including a tablet path distribution corresponding to the tablet bed in the pan;
(ii) randomly selecting via a Monte Carlo simulation method, a tablet path for each cycle of a simulation tablet within the tablet bed;
(iii) calculating a coating amount for at least one cycle of the simulation tablet based on the assigned tablet path;
(iv) summing the calculated coating amounts for the at least one cycle of the simulation tablet to produce a tablet coating weight;
(v) repeating steps (ii)-(iv) for each of a defined number of simulation tablets representing the plurality of tablets;
(vi) determining at least one of tablet coating uniformity or coated tablet weight uniformity for the plurality of tablets based at least in part on the tablet coating weight for each of the simulation tablets;
and
(vii) setting operating conditions of pan coating equipment based on the purality of parameters and at least one of the determined tablet coating uniformity or the determined coated tablet weight uniformity for the plurality of tablets;
wherein the pan has a shape including at least one cylindrical portion and at least one non-cylindrical portion and the tablet bed has an associated shape corresponding to the shape of the pan and wherein the tablet path distribution is a volume based distribution corresponding to the associated shape of the tablet bed.

6 more elements

A magnetic disk, optical disk or memory card of claim including software that is configured to control a computer to implement a method for simulating a pan coating process to estimate at least one of tablet coating uniformity or coated tablet weight uniformity for a plurality of tablets, the pan coating process cycling the plurality of tablets within a tablet bed in a pan, the method comprising the steps of:

(i) obtaining a plurality of parameters associated with the pan coating process, the plurality of parameters including a desired coating time and a cycle time distribution, and a tablet bypass distribution for bypassing a simulation spray zone associated with the tablet bed;
(ii) randomly assigning via a Monte Carlo simulation method, a cycle time for each cycle of a simulation;
(iii) summing the cycle times assigned to each cycle;
(iv) randomly selecting whether the simulation tablet passes through the simulation spray zone or bypasses the simulation spray zone in accordance with the tablet bypass distribution fur each cycle of the simulation tablet;
(v) calculating a cycle coating amount only for cycles of the simulation tablet passing through the simulation spray zone;
(vi) repeating steps (ii)-(v) until a sum of the cycle times from step (iii) is greater than or equal to the desired coating time to identify a number of cycles for the simulation tablet;
(vii) determining a tablet coating weight for the simulation tablet based on the number of cycles;
(viii) repeating steps (ii)-(vii) for each of a defined number of simulation tablets representing the plurality of tablets;
(ix) determining at least one of tablet coating uniformity or coated tablet weight uniformity for the plurality of tablets based at least in part on the tablet coating weight for each of the simulation tablets;
and
(x) setting operating conditions of pan coating equipment based on the plurality of parameters and at least one of the determined tablet coating uniformity or the determined coated tablet weight uniformity for the plurality of tablets.

8 more elements

Pan coating simulation for determining tablet coating uniformity

Life of this patent

Pan coating simulation for determining tablet coating uniformity

Life of this patent

Abstract

Claims31