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Pharmacotherapy Update

Evaluating Topical Drug Delivery Systems: the Tube vs. the Pump

June 2007

Combination products containing clindamycin 1%/benzoyl peroxide 5% are commonly used for managing acne. Several studies have demonstrated the superior efficacy of the combination compared to either ingredient alone. Formerly, topical formulations of benzoyl peroxide (BPO) and antibiotics in solution required compounding; however, premixed BPO/clindamycin gel preparations are now available.

As has been demonstrated, patient preference greatly influences compliance with treatment regimens and is based on a variety of factors including perceived safety and side effect profile, dosing schedule, convenience, cosmetic attributes and packaging. More consistent adherence to treatment is much more likely to translate to improved efficacy.
Perceptions of product safety include not only side effects, but also product stability and the risk of product contamination in some types of packaging. Convenience and ease of dispensing may also differ according to packaging type (for example, jar, tube or pump).

This study compares two clindamycin 1%/BPO 5% gel formulations — one in an aqueous base containing dimethicone and glycerin dispensed from a tube and one (without dimethicone and glycerin) dispensed via a pump canister.
The amount of drug used was assessed, as well as the convenience, and cost-effectiveness of the two types of product packaging as a function of applied amount versus number of pumps, based on U.S. Food and Drug Administration-approved frequency recommendations (twice-daily versus once-daily dispensing).

Why Determining the Quantity of Drug Used Is Important

It has been shown that convenience, ease of dispensing and favorable tolerability are key characteristics that may increase patient compliance with topical dermatologic therapy.1-3

Additionally, the quantity of drug utilized with topical application may be affected by the type of vehicle used, characteristics such as viscosity, and the type of packaging used (for example, a tube, jar, pump canister, etc). Under-utilization of a product will not produce optimal results within a given treatment period whereas over-utilization of a topical product leads to waste, an increased risk of irritation and other side effects and overall increased costs of therapy.

The amount of medication used correlates directly with the cost of a given intervention over time. Third-party payers frequently base reimbursement and the amount of a topical medication dispensed on what they deem an appropriate quantity for a given treatment period. Exceeding this amount may result in increased medication costs.4

Determination of drug quantity used per application is important both to optimize product use without waste and to predict how long a given quantity of a prescribed drug should last if applied according to instructions.

In a recent study of quantities of medication delivered in different vehicles, patients were taught a recommended application method. Using this recommended application, they used four different vehicle types: cream, thick cream, lotion and gel once daily for 7 days.
The benzoyl peroxide (BPO) 5%/ clindamycin 1% containing dimethicone and glycerin was dispensed in a tube, and the other BPO/clindamycin gel in a jar. The mean single-use application for the tube gel was 0.69 g and 0.80 g for the jar gel (n=20).4

Understanding the quantity of product used per application can predict how long a given quantity of prescribed drug should last, if applied appropriately. For example, the mean quantity of BPO 5%/clindamycin 1% containing dimethicone and glycerin in a water-based gel dispensed in a tube (Duac Gel) was evaluated. When applied once daily over a 30-day period, the amount of treatment that should be applied was 21 g. Based on this application rate, a 45-g trade-size tube would last approximately 2 months.4

Dispensing Benzoyl Peroxide 5%/ Clindamycin 1% Gel in a Pump Canister

• BPO 5%/clindamycin 1% gel is now available dispensed from a pump applicator (BenzaClin). Unlike the BPO 5%/clindamycin 1% gel formulation dispensed from a tube, this product is mixed before dispensing to the patient.
• This study was initiated to determine the amount of medication dispensed from the pump canister, uniformity of dispensation, number of applications per pump canister, and the amounts of product remaining in the pump canister.

Methods Used for Preparing and Testing Samples

• Samples were mixed by adding the directed amount of purified water to the clindamycin container and shaking it until all of the drug was dissolved. The water level was checked and if it was below the marked line on the container, then more water was added until it reached the line. The sample was shaken again to ensure that the drug was mixed with the newly added water. This mixture was then added to the container of BPO and mixed in a clockwise direction for 45 seconds and then in a counter-clockwise direction for 45 seconds, mixing at a speed of about one revolution per second. As much of the mixture as possible was wiped from the paddle and returned to the canister. The pump top was placed on the canister and screwed on tightly.
• Two pump canisters were tested for dose uniformity, number of applications, and product residue remaining once no more product could be dispensed via the pump. Each sample was also tested as follows:
o Each time the pump was pressed, the amount of dispensed gel was weighed and recorded. Once the gel no longer dispensed from the container, the jar, pump and remaining product residue were weighed.
o The canister and pump were then disassembled, cleaned and dried before weighing to determine the bulk remaining in the container.
• Samples were tested for delivery of the gel at room temperature. Samples were tested as follows.
o One container was designated for daily dispensing (Pump 1), and one for twice-daily dispensing (Pump 2). Each dispensed weight was recorded to evaluate how the delivered dose changed over time when dispensed as recommended by the physician.
o Physical evaluations were also recorded to include (but were not limited to) pump clogging and container air pockets.
• One sample was also mixed and submitted for analytical chemistry testing of BPO and clindamycin along with its degradates from the top and bottom of the jar. Samples were taken at the beginning, middle and end of the product dispensation and tested in duplicate.

Results of Dose Uniformity Testing

• The average amount of dispensed product was the same for both pump canisters, Pump 1 dispensed 50.52 g overall vs. 48.89 g for Pump 2. Two full pumps were required to “prime” each of the pump units before medication was retrieved from the nozzle.

Results of In-Use Testing

• For daily dosing, a total of 49.03 g of product was dispensed with an average dispense weight of 1.29 g per press of the pump dispenser (for 2 to 25 pumps as noted in Figure 1). After the the pump dispenser was pressed 25 times, 63% of the product was dispensed, and the amount dispensed per pump press was less consistent.
• For twice-daily dosing, the amount of product dispensed was 48.59 g, with an average dispense weight of 1.33 g per press of the pump dispenser. After the the pump dispenser was pressed 30 times, 71% of the product was dispensed and the amount dispensed per pump press was less consistent.

Results of Chemistry Testing

• The results of chemistry testing are summarized in Table 1. The average BPO content was 5.06%, and the average clindamycin content was 1.10%.

Assessing Usage Amounts

• The average amount of product dispensed from each of the two pump canisters per pump press was 1.29 g and 1.33 g, respectively. After pump number 25, the amount of gel dispensed per pump press became inconsistent, and in some cases no product was dispensed by the pump canister.
• Under typical prescribing conditions of use, a pump canister unit lasted for 40 days of daily dosing and 21 days of twice-daily dosing.
• Based on the results of this analysis and a previous study evaluating quantity of gel needed to achieve complete facial coverage per application session, more product than necessary was dispensed with each pump press.4 Under typical prescribing conditions using the pump dispenser unit, a patient would need to refill the prescription every 21 days for twice-daily dosing and every 40 days for daily dosing.
• From dose and drug utilization perspectives, the previous qualitative and quantitative topical application study demonstrated that 0.69 g of the topical BPO 5%/clindamycin 1% gel formulation (containing moisturizers dimethicone and glycerin) dispensed from a tube was needed for optimum coverage of the face.4 Following patient education regarding correct application, usage was within 0.01 g of this amount for 7 out of 10 patients using the tube gel.
• From the practical perspective of product use by patients based on comparisons of the currently available BPO 5%/clindamycin 1% tube and pump, properly retrieving medication from the tube may be more consistent and appears to make it easier for the patient to estimate and control how much product is used per application. This dispensing method enables avoidance of both product waste, which is economically disadvantageous, and also for excessive application of medication to facial skin, which may lead to increased irritation in some patients. Importantly, patient education regarding proper use and amount of medication based on the type of packaging (ie, tube, pump, jar) is a vital component of treatment success and reduced waste of product.
• From an economic standpoint, the BPO/clindamycin gel tube would appear to offer an advantage over the gel pump. Within typical usage conditions as demonstrated in this study, patients are apt to dispense anywhere from 1.29 g and 1.33 g per pump press. Assuming that 1.29 g per day is dispensed, the BPO/clindamycin pump product would need to be replaced after 39 days for patients on a daily dosing schedule and after 19 days for patients on a twice daily dosing schedule (Figure 2).
• These findings suggest that BPO 5%/clindamycin 1% gel is more economical when dispensed from the
45-g tube rather than the 50-g pump canister. This conclusion is based on studies specifically using these available brand formulation containers. In addition to the direct costs and/or co-pay frequency of purchasing the medication, indirect costs should be considered such as transportation to the pharmacy, lost therapy time, and physician or office time required to provide new prescriptions.

Points to Remember

1. This study found that the amount of BPO 5%/clindamycin 1% gel dispensed from a 50-g pump canister was not consistent after approximately 25 uses (pump presses). In some cases, air pockets prevented the release of product even when gel remained in the canister.
2. The BPO 5%/clindamycin 1% pump canister yielded an average of 1.29 g per pump press, over half a gram more than the 0.69 g needed to achieve facial coverage per application session with the tube gel formulation. Overuse of medication contributes to product waste and increased cost. Over-application of medication increases the potential for application-site reactions and signs and symptoms of skin irritation, at least in some patients.
3. Based on the results reported above and in other applicable studies, BPO 5%/clindamycin 1% gel dispensed from a tube is more economical than the formulation that is dispensed in a pump canister, provided patients are educated on proper method of application. Taking into account methodology used in this study and in previous analyses, the 45-g tube lasts longer than the 50-g pump canister, thus resulting in reduced direct and indirect costs for the medication.


 

 

 

 

Combination products containing clindamycin 1%/benzoyl peroxide 5% are commonly used for managing acne. Several studies have demonstrated the superior efficacy of the combination compared to either ingredient alone. Formerly, topical formulations of benzoyl peroxide (BPO) and antibiotics in solution required compounding; however, premixed BPO/clindamycin gel preparations are now available.

As has been demonstrated, patient preference greatly influences compliance with treatment regimens and is based on a variety of factors including perceived safety and side effect profile, dosing schedule, convenience, cosmetic attributes and packaging. More consistent adherence to treatment is much more likely to translate to improved efficacy.
Perceptions of product safety include not only side effects, but also product stability and the risk of product contamination in some types of packaging. Convenience and ease of dispensing may also differ according to packaging type (for example, jar, tube or pump).

This study compares two clindamycin 1%/BPO 5% gel formulations — one in an aqueous base containing dimethicone and glycerin dispensed from a tube and one (without dimethicone and glycerin) dispensed via a pump canister.
The amount of drug used was assessed, as well as the convenience, and cost-effectiveness of the two types of product packaging as a function of applied amount versus number of pumps, based on U.S. Food and Drug Administration-approved frequency recommendations (twice-daily versus once-daily dispensing).

Why Determining the Quantity of Drug Used Is Important

It has been shown that convenience, ease of dispensing and favorable tolerability are key characteristics that may increase patient compliance with topical dermatologic therapy.1-3

Additionally, the quantity of drug utilized with topical application may be affected by the type of vehicle used, characteristics such as viscosity, and the type of packaging used (for example, a tube, jar, pump canister, etc). Under-utilization of a product will not produce optimal results within a given treatment period whereas over-utilization of a topical product leads to waste, an increased risk of irritation and other side effects and overall increased costs of therapy.

The amount of medication used correlates directly with the cost of a given intervention over time. Third-party payers frequently base reimbursement and the amount of a topical medication dispensed on what they deem an appropriate quantity for a given treatment period. Exceeding this amount may result in increased medication costs.4

Determination of drug quantity used per application is important both to optimize product use without waste and to predict how long a given quantity of a prescribed drug should last if applied according to instructions.

In a recent study of quantities of medication delivered in different vehicles, patients were taught a recommended application method. Using this recommended application, they used four different vehicle types: cream, thick cream, lotion and gel once daily for 7 days.
The benzoyl peroxide (BPO) 5%/ clindamycin 1% containing dimethicone and glycerin was dispensed in a tube, and the other BPO/clindamycin gel in a jar. The mean single-use application for the tube gel was 0.69 g and 0.80 g for the jar gel (n=20).4

Understanding the quantity of product used per application can predict how long a given quantity of prescribed drug should last, if applied appropriately. For example, the mean quantity of BPO 5%/clindamycin 1% containing dimethicone and glycerin in a water-based gel dispensed in a tube (Duac Gel) was evaluated. When applied once daily over a 30-day period, the amount of treatment that should be applied was 21 g. Based on this application rate, a 45-g trade-size tube would last approximately 2 months.4

Dispensing Benzoyl Peroxide 5%/ Clindamycin 1% Gel in a Pump Canister

• BPO 5%/clindamycin 1% gel is now available dispensed from a pump applicator (BenzaClin). Unlike the BPO 5%/clindamycin 1% gel formulation dispensed from a tube, this product is mixed before dispensing to the patient.
• This study was initiated to determine the amount of medication dispensed from the pump canister, uniformity of dispensation, number of applications per pump canister, and the amounts of product remaining in the pump canister.

Methods Used for Preparing and Testing Samples

• Samples were mixed by adding the directed amount of purified water to the clindamycin container and shaking it until all of the drug was dissolved. The water level was checked and if it was below the marked line on the container, then more water was added until it reached the line. The sample was shaken again to ensure that the drug was mixed with the newly added water. This mixture was then added to the container of BPO and mixed in a clockwise direction for 45 seconds and then in a counter-clockwise direction for 45 seconds, mixing at a speed of about one revolution per second. As much of the mixture as possible was wiped from the paddle and returned to the canister. The pump top was placed on the canister and screwed on tightly.
• Two pump canisters were tested for dose uniformity, number of applications, and product residue remaining once no more product could be dispensed via the pump. Each sample was also tested as follows:
o Each time the pump was pressed, the amount of dispensed gel was weighed and recorded. Once the gel no longer dispensed from the container, the jar, pump and remaining product residue were weighed.
o The canister and pump were then disassembled, cleaned and dried before weighing to determine the bulk remaining in the container.
• Samples were tested for delivery of the gel at room temperature. Samples were tested as follows.
o One container was designated for daily dispensing (Pump 1), and one for twice-daily dispensing (Pump 2). Each dispensed weight was recorded to evaluate how the delivered dose changed over time when dispensed as recommended by the physician.
o Physical evaluations were also recorded to include (but were not limited to) pump clogging and container air pockets.
• One sample was also mixed and submitted for analytical chemistry testing of BPO and clindamycin along with its degradates from the top and bottom of the jar. Samples were taken at the beginning, middle and end of the product dispensation and tested in duplicate.

Results of Dose Uniformity Testing

• The average amount of dispensed product was the same for both pump canisters, Pump 1 dispensed 50.52 g overall vs. 48.89 g for Pump 2. Two full pumps were required to “prime” each of the pump units before medication was retrieved from the nozzle.

Results of In-Use Testing

• For daily dosing, a total of 49.03 g of product was dispensed with an average dispense weight of 1.29 g per press of the pump dispenser (for 2 to 25 pumps as noted in Figure 1). After the the pump dispenser was pressed 25 times, 63% of the product was dispensed, and the amount dispensed per pump press was less consistent.
• For twice-daily dosing, the amount of product dispensed was 48.59 g, with an average dispense weight of 1.33 g per press of the pump dispenser. After the the pump dispenser was pressed 30 times, 71% of the product was dispensed and the amount dispensed per pump press was less consistent.

Results of Chemistry Testing

• The results of chemistry testing are summarized in Table 1. The average BPO content was 5.06%, and the average clindamycin content was 1.10%.

Assessing Usage Amounts

• The average amount of product dispensed from each of the two pump canisters per pump press was 1.29 g and 1.33 g, respectively. After pump number 25, the amount of gel dispensed per pump press became inconsistent, and in some cases no product was dispensed by the pump canister.
• Under typical prescribing conditions of use, a pump canister unit lasted for 40 days of daily dosing and 21 days of twice-daily dosing.
• Based on the results of this analysis and a previous study evaluating quantity of gel needed to achieve complete facial coverage per application session, more product than necessary was dispensed with each pump press.4 Under typical prescribing conditions using the pump dispenser unit, a patient would need to refill the prescription every 21 days for twice-daily dosing and every 40 days for daily dosing.
• From dose and drug utilization perspectives, the previous qualitative and quantitative topical application study demonstrated that 0.69 g of the topical BPO 5%/clindamycin 1% gel formulation (containing moisturizers dimethicone and glycerin) dispensed from a tube was needed for optimum coverage of the face.4 Following patient education regarding correct application, usage was within 0.01 g of this amount for 7 out of 10 patients using the tube gel.
• From the practical perspective of product use by patients based on comparisons of the currently available BPO 5%/clindamycin 1% tube and pump, properly retrieving medication from the tube may be more consistent and appears to make it easier for the patient to estimate and control how much product is used per application. This dispensing method enables avoidance of both product waste, which is economically disadvantageous, and also for excessive application of medication to facial skin, which may lead to increased irritation in some patients. Importantly, patient education regarding proper use and amount of medication based on the type of packaging (ie, tube, pump, jar) is a vital component of treatment success and reduced waste of product.
• From an economic standpoint, the BPO/clindamycin gel tube would appear to offer an advantage over the gel pump. Within typical usage conditions as demonstrated in this study, patients are apt to dispense anywhere from 1.29 g and 1.33 g per pump press. Assuming that 1.29 g per day is dispensed, the BPO/clindamycin pump product would need to be replaced after 39 days for patients on a daily dosing schedule and after 19 days for patients on a twice daily dosing schedule (Figure 2).
• These findings suggest that BPO 5%/clindamycin 1% gel is more economical when dispensed from the
45-g tube rather than the 50-g pump canister. This conclusion is based on studies specifically using these available brand formulation containers. In addition to the direct costs and/or co-pay frequency of purchasing the medication, indirect costs should be considered such as transportation to the pharmacy, lost therapy time, and physician or office time required to provide new prescriptions.

Points to Remember

1. This study found that the amount of BPO 5%/clindamycin 1% gel dispensed from a 50-g pump canister was not consistent after approximately 25 uses (pump presses). In some cases, air pockets prevented the release of product even when gel remained in the canister.
2. The BPO 5%/clindamycin 1% pump canister yielded an average of 1.29 g per pump press, over half a gram more than the 0.69 g needed to achieve facial coverage per application session with the tube gel formulation. Overuse of medication contributes to product waste and increased cost. Over-application of medication increases the potential for application-site reactions and signs and symptoms of skin irritation, at least in some patients.
3. Based on the results reported above and in other applicable studies, BPO 5%/clindamycin 1% gel dispensed from a tube is more economical than the formulation that is dispensed in a pump canister, provided patients are educated on proper method of application. Taking into account methodology used in this study and in previous analyses, the 45-g tube lasts longer than the 50-g pump canister, thus resulting in reduced direct and indirect costs for the medication.


 

 

 

 

Combination products containing clindamycin 1%/benzoyl peroxide 5% are commonly used for managing acne. Several studies have demonstrated the superior efficacy of the combination compared to either ingredient alone. Formerly, topical formulations of benzoyl peroxide (BPO) and antibiotics in solution required compounding; however, premixed BPO/clindamycin gel preparations are now available.

As has been demonstrated, patient preference greatly influences compliance with treatment regimens and is based on a variety of factors including perceived safety and side effect profile, dosing schedule, convenience, cosmetic attributes and packaging. More consistent adherence to treatment is much more likely to translate to improved efficacy.
Perceptions of product safety include not only side effects, but also product stability and the risk of product contamination in some types of packaging. Convenience and ease of dispensing may also differ according to packaging type (for example, jar, tube or pump).

This study compares two clindamycin 1%/BPO 5% gel formulations — one in an aqueous base containing dimethicone and glycerin dispensed from a tube and one (without dimethicone and glycerin) dispensed via a pump canister.
The amount of drug used was assessed, as well as the convenience, and cost-effectiveness of the two types of product packaging as a function of applied amount versus number of pumps, based on U.S. Food and Drug Administration-approved frequency recommendations (twice-daily versus once-daily dispensing).

Why Determining the Quantity of Drug Used Is Important

It has been shown that convenience, ease of dispensing and favorable tolerability are key characteristics that may increase patient compliance with topical dermatologic therapy.1-3

Additionally, the quantity of drug utilized with topical application may be affected by the type of vehicle used, characteristics such as viscosity, and the type of packaging used (for example, a tube, jar, pump canister, etc). Under-utilization of a product will not produce optimal results within a given treatment period whereas over-utilization of a topical product leads to waste, an increased risk of irritation and other side effects and overall increased costs of therapy.

The amount of medication used correlates directly with the cost of a given intervention over time. Third-party payers frequently base reimbursement and the amount of a topical medication dispensed on what they deem an appropriate quantity for a given treatment period. Exceeding this amount may result in increased medication costs.4

Determination of drug quantity used per application is important both to optimize product use without waste and to predict how long a given quantity of a prescribed drug should last if applied according to instructions.

In a recent study of quantities of medication delivered in different vehicles, patients were taught a recommended application method. Using this recommended application, they used four different vehicle types: cream, thick cream, lotion and gel once daily for 7 days.
The benzoyl peroxide (BPO) 5%/ clindamycin 1% containing dimethicone and glycerin was dispensed in a tube, and the other BPO/clindamycin gel in a jar. The mean single-use application for the tube gel was 0.69 g and 0.80 g for the jar gel (n=20).4

Understanding the quantity of product used per application can predict how long a given quantity of prescribed drug should last, if applied appropriately. For example, the mean quantity of BPO 5%/clindamycin 1% containing dimethicone and glycerin in a water-based gel dispensed in a tube (Duac Gel) was evaluated. When applied once daily over a 30-day period, the amount of treatment that should be applied was 21 g. Based on this application rate, a 45-g trade-size tube would last approximately 2 months.4

Dispensing Benzoyl Peroxide 5%/ Clindamycin 1% Gel in a Pump Canister

• BPO 5%/clindamycin 1% gel is now available dispensed from a pump applicator (BenzaClin). Unlike the BPO 5%/clindamycin 1% gel formulation dispensed from a tube, this product is mixed before dispensing to the patient.
• This study was initiated to determine the amount of medication dispensed from the pump canister, uniformity of dispensation, number of applications per pump canister, and the amounts of product remaining in the pump canister.

Methods Used for Preparing and Testing Samples

• Samples were mixed by adding the directed amount of purified water to the clindamycin container and shaking it until all of the drug was dissolved. The water level was checked and if it was below the marked line on the container, then more water was added until it reached the line. The sample was shaken again to ensure that the drug was mixed with the newly added water. This mixture was then added to the container of BPO and mixed in a clockwise direction for 45 seconds and then in a counter-clockwise direction for 45 seconds, mixing at a speed of about one revolution per second. As much of the mixture as possible was wiped from the paddle and returned to the canister. The pump top was placed on the canister and screwed on tightly.
• Two pump canisters were tested for dose uniformity, number of applications, and product residue remaining once no more product could be dispensed via the pump. Each sample was also tested as follows:
o Each time the pump was pressed, the amount of dispensed gel was weighed and recorded. Once the gel no longer dispensed from the container, the jar, pump and remaining product residue were weighed.
o The canister and pump were then disassembled, cleaned and dried before weighing to determine the bulk remaining in the container.
• Samples were tested for delivery of the gel at room temperature. Samples were tested as follows.
o One container was designated for daily dispensing (Pump 1), and one for twice-daily dispensing (Pump 2). Each dispensed weight was recorded to evaluate how the delivered dose changed over time when dispensed as recommended by the physician.
o Physical evaluations were also recorded to include (but were not limited to) pump clogging and container air pockets.
• One sample was also mixed and submitted for analytical chemistry testing of BPO and clindamycin along with its degradates from the top and bottom of the jar. Samples were taken at the beginning, middle and end of the product dispensation and tested in duplicate.

Results of Dose Uniformity Testing

• The average amount of dispensed product was the same for both pump canisters, Pump 1 dispensed 50.52 g overall vs. 48.89 g for Pump 2. Two full pumps were required to “prime” each of the pump units before medication was retrieved from the nozzle.

Results of In-Use Testing

• For daily dosing, a total of 49.03 g of product was dispensed with an average dispense weight of 1.29 g per press of the pump dispenser (for 2 to 25 pumps as noted in Figure 1). After the the pump dispenser was pressed 25 times, 63% of the product was dispensed, and the amount dispensed per pump press was less consistent.
• For twice-daily dosing, the amount of product dispensed was 48.59 g, with an average dispense weight of 1.33 g per press of the pump dispenser. After the the pump dispenser was pressed 30 times, 71% of the product was dispensed and the amount dispensed per pump press was less consistent.

Results of Chemistry Testing

• The results of chemistry testing are summarized in Table 1. The average BPO content was 5.06%, and the average clindamycin content was 1.10%.

Assessing Usage Amounts

• The average amount of product dispensed from each of the two pump canisters per pump press was 1.29 g and 1.33 g, respectively. After pump number 25, the amount of gel dispensed per pump press became inconsistent, and in some cases no product was dispensed by the pump canister.
• Under typical prescribing conditions of use, a pump canister unit lasted for 40 days of daily dosing and 21 days of twice-daily dosing.
• Based on the results of this analysis and a previous study evaluating quantity of gel needed to achieve complete facial coverage per application session, more product than necessary was dispensed with each pump press.4 Under typical prescribing conditions using the pump dispenser unit, a patient would need to refill the prescription every 21 days for twice-daily dosing and every 40 days for daily dosing.
• From dose and drug utilization perspectives, the previous qualitative and quantitative topical application study demonstrated that 0.69 g of the topical BPO 5%/clindamycin 1% gel formulation (containing moisturizers dimethicone and glycerin) dispensed from a tube was needed for optimum coverage of the face.4 Following patient education regarding correct application, usage was within 0.01 g of this amount for 7 out of 10 patients using the tube gel.
• From the practical perspective of product use by patients based on comparisons of the currently available BPO 5%/clindamycin 1% tube and pump, properly retrieving medication from the tube may be more consistent and appears to make it easier for the patient to estimate and control how much product is used per application. This dispensing method enables avoidance of both product waste, which is economically disadvantageous, and also for excessive application of medication to facial skin, which may lead to increased irritation in some patients. Importantly, patient education regarding proper use and amount of medication based on the type of packaging (ie, tube, pump, jar) is a vital component of treatment success and reduced waste of product.
• From an economic standpoint, the BPO/clindamycin gel tube would appear to offer an advantage over the gel pump. Within typical usage conditions as demonstrated in this study, patients are apt to dispense anywhere from 1.29 g and 1.33 g per pump press. Assuming that 1.29 g per day is dispensed, the BPO/clindamycin pump product would need to be replaced after 39 days for patients on a daily dosing schedule and after 19 days for patients on a twice daily dosing schedule (Figure 2).
• These findings suggest that BPO 5%/clindamycin 1% gel is more economical when dispensed from the
45-g tube rather than the 50-g pump canister. This conclusion is based on studies specifically using these available brand formulation containers. In addition to the direct costs and/or co-pay frequency of purchasing the medication, indirect costs should be considered such as transportation to the pharmacy, lost therapy time, and physician or office time required to provide new prescriptions.

Points to Remember

1. This study found that the amount of BPO 5%/clindamycin 1% gel dispensed from a 50-g pump canister was not consistent after approximately 25 uses (pump presses). In some cases, air pockets prevented the release of product even when gel remained in the canister.
2. The BPO 5%/clindamycin 1% pump canister yielded an average of 1.29 g per pump press, over half a gram more than the 0.69 g needed to achieve facial coverage per application session with the tube gel formulation. Overuse of medication contributes to product waste and increased cost. Over-application of medication increases the potential for application-site reactions and signs and symptoms of skin irritation, at least in some patients.
3. Based on the results reported above and in other applicable studies, BPO 5%/clindamycin 1% gel dispensed from a tube is more economical than the formulation that is dispensed in a pump canister, provided patients are educated on proper method of application. Taking into account methodology used in this study and in previous analyses, the 45-g tube lasts longer than the 50-g pump canister, thus resulting in reduced direct and indirect costs for the medication.


 

 

 

 

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