what is bulk powder in pharmacy

Full Answer

What are bulk powders?

Bulk powders Bulk powders refer to a mixture of all the materials (usually non-potent drugs), packed into a properly designed bulk containers, such as a tight, wide-mouthed glass or plastic bottle, and are intended for either internal or external administration. The major problem of bulk powders is the inaccuracy of dose.

What is a powder in pharmacy?

The term “powder” has more than one connotation in pharmacy. It may be used to describe the physical form of a material, that is, a dry substance composed of finely divided particles that may be used as the basis of many other solid dosage forms such as tablets, capsules, etc. Powders may also be used to describe a type of pharmaceutical ...

How are powders classified?

Classification of powders based on dispensing Pharmaceutical powders are classified based on dispensing or by the way they are presented to the user into bulk or divided powders. a. Bulk powders

How is the dose of bulk powder determined?

The dose of bulk powder may vary for patients using differently sized spoons, or even those using the same spoon according to their technique. In addition, drugs present in the bulk powders are better suited, if they have a wider therapeutic window, a large dose, and pleasant taste.

What is bulk powder?

What is the major problem of bulk powders?

What is divided powder?

Why do you use dusting powder?

What is powder form?

Is oral powder faster than capsules?

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What is bulk powder used for?

Bulking powders are BIG business within the world of bodybuilding, as they're essentially used to help people 'bulk' up their muscle mass.

What are types of bulk powders?

The limited prescriptions of bulk powders in the oral form are antacids, dietary supplements, laxatives, and pain relievers. The vast majority of bulk powders are topical.

What are bulk oral powders?

Bulk oral powders are limited to relatively nonpotent drugs such as laxatives, antacids, dietary supplements, and certain analgesics that the patient may safely measure by the teaspoonful or capful. Other bulky powders include douche powders, tooth powders, and dusting powders.

How are bulk powders dispensed?

Packaging of pharmaceutical powders Divided powders are dispensed in the form of individual doses and generally are dispensed in papers, properly folded. They also may be dispensed in metal foil, small heat-sealed plastic bags, or other containers.

What are different types of powders?

Types. Many manufactured goods come in powder form, such as flour, sugar, ground coffee, powdered milk, copy machine toner, gunpowder, cosmetic powders, and some pharmaceuticals. In nature, dust, fine sand and snow, volcanic ash, and the top layer of the lunar regolith are also examples.

What is simple powder in pharmacy?

Simple & Compound Powders for Internal Use  SIMPLE POWDER: - In simple powder contains only one ingredient either in crystalline form or amorphous form. - If powder present in crystalline form then it is reduced to fine powder, weighed the powder & divided into number of doses & wrapped as individual dose.

What is posology in pharmacy?

The science of dosage or posology (from Greek posos, how much, and logos, study) is a branch of pharmacology and therapeutics concerned with 'treatment dosage' and 'dosage regimen'. Establishing optimum dosage underpins every clinical development plan for novel therapeutic candidates.

What is the effervescent powder?

Effervescent powder formulation having self-refrigerant power that consists of a mixture of sodium bicarbonate, citric acid, and tartaric acid, useful for obtaining an instant sparkling beverage.

What is coarse powder?

Coarse powder A powder all the particles of which pass through a sieve with a nominal mesh aperture of 1700 ~ and not more than 40 percent by weight through a sieve with a nominal mesh aperture of 355 ~.

What are advantages of powders?

Advantages of Powders There is a wide choice of ingredients, and the dose can easily be achieved for patient administration. 2. Powders have better physicochemical stability and longer shelf life compared to liquid dosage forms.

What is the difference between simple and compound powder?

A compound powder has more than one ingredient, such as simple powder but less than one is simple powder. To make powders easily handled by patients and weighed accurately, the minimum quantity of each powder should not be less than 100 mg.

What are granules pharmacy?

Granulation, a technique of particle enlargement by agglomeration, is one of the most significant unit operations in the production of pharmaceutical dosage forms, mostly tablets and capsules. 1. During the granulation process, small fine or coarse particles are converted into large agglomerates called granules.

What are the types of powder papers available?

34 Powder Papers - Four basic types of powder papers are available.Vegetable parchment, a thin semi-opaque moisture-resistant paper.White bond, an opaque paper with no moisture-resistant properties.Glassine, a glazed, transparent moisture-resistant paper.

What are the types of tablet?

There are different types of tablets:Chewable tablets dissolve and are absorbed rapidly in the stomach, offering a quick onset of action. ... Orally disintegrating tablets dissolve on the tongue. ... Sublingual tablets go under the tongue. ... Effervescent tablets are dissolved in liquid and then drunk.

What is the example of dusting powder?

Dusting-powder definition A fine powder, such as talcum powder, used on the skin. Any fine, light powder used as an insecticide, medicine, toiletry, etc., or used to prevent sticking. The definition of a dusting powder is fine light powder used on the skin.

What is the difference between compressed tablet and tablet Triturates?

The differences between the two dosage forms under study occurred mainly because the compressed tablets have a more porous surface, while the tablet triturates have a smooth surface, resulting in a greater difficulty associated with the absorption of the impregnation solution.

POWDER DOSAGE FORMS - POWDER DOSAGE FORMS Powder... - Course Hero

Divided Powders • Divided powders are dispensed in individual dose units. • The powders are usually light to moderate in density and never granular. • The majority of the time, the powders are dispensed in paper which is specifically folded to keep the powder in place. [similar to a chewing gum wrapper] • The specific folding of the paper keeps the powder flat. allowing no caking of ...

Four Solid Dosage Forms - Powders, Granules, Capsules, and Tablets

Pharmaceutical dosage forms can be classified into liquids, gases, solids, and semi-solids depending on the form. Most drugs are developed for oral administration of a solid dosage form. Among them, powders, granules, capsules, and tablets are common solid dosage forms.

I.Types of powders based on particle size

According to British Standard 1993, any distinct particle of size less than 1000µm is called powder. The degree of fineness of the powder is indicated by the nominal mesh aperture size of the sieve.

II. Type of Powder Based on Dispensing

This is another classification of powder generally based on the manner of dispensing. This section is covering different types and their uses.

III. Types of Powder Based on Use

Based on use pharmaceutical powders are classified for internal and external use.

IV. SPECIAL POWDERS

Eutectic powders are ingredients having a low melting point, upon mixing, rubbing, or trituration they turn into liquid form. For instance, menthol, thymol, or camphor powder.

Conclusion

With the development of formulation sciences, powder has been compounded with more precision and accuracy. Although the main applications of powder are now substituted with tablets and capsules, still many key products are available in powder form.

What is bulk powder?

Bulk powders refer to a mixture of all the materials (usually non-potent drugs), packed into a properly designed bulk containers, such as a tight, wide-mouthed glass or plastic bottle, and are intended for either internal or external administration. The major problem of bulk powders is the inaccuracy of dose.

What is a pharmaceutical powder?

Pharmaceutical powders for internal use are preparations consisting of solid, loose, dry particles of varying degrees of fine particle size that contain one or more active substances, with or without excipients.

What is the name of the drug that is dissolved in warm water?

antacids (e.g., sodium bicarbonate) and laxatives (e.g., psyllium [Metamucil]), which the patient takes by mixing with water or other beverages before swallowing; douche powders (e.g., Massengill powder), dissolved in warm water by the patient for vaginal use;

What is powder medicine?

Powders are solid dosage form containing dry mixtures of finely divided drug substance (s) and excipients intended for internal or external use. Although the use of powders as a dosage form has been replaced largely by the use of tablets and capsules in modern medicine, they represent one of the oldest dosage forms and present certain advantages that have led to their continued use as pharmaceutical dosage forms.

What is a topical powder?

Topical powders also known as powders for cutaneous application or powders for external use are preparations consisting of solid, loose, dry particles of varying degrees of fineness. They contain one or more active substances, with or without excipients and, if necessary, appropriate coloring matter.

How are powders classified?

Powders can be classified in various ways and these include. Classification based on use. Classification based on particle size and. Classification based on dispensing/ by the way they are presented to the user. Contents [ show] 1 1. Classification of powders based on use. 1.1 a.

How many mm does a powder pass through?

a. Very coarse (No. 8) powder: All particles pass through a No. 8 sieve (2.38 mm) and not more than 20% pass through a No. 60 sieve.

Why do compounders need to know their bulk supplier?

The agency urges compounders to know your bulks supplier because compounding from bulk drug substances presents risks to patients. Additionally, sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act place limits on the bulk drug substances that can be used in compounding.

What is compounding in medicine?

Compounders sometimes produce drugs using bulk drug substances, also known as active pharmaceutical ingredients. For example, when a patient has an allergy to an ingredient in an FDA-approved drug, a state-licensed pharmacist or physician, or an outsourcing facility, might compound a drug product using a bulk drug substance that does not contain the allergen.

When will compounding change?

See changes that affect compounding as of March 23, 2020, for information about biological products that were approved under the Federal Food, Drug, and Cosmetic (FD&C) Act will transition to being licensed under the Public Health Service (PHS) Act.

Can a pharmacist use 503A?

State-licensed physicians and pharmacists seeking to operate under section 503A, may only use bulk drug substances in compounding drug products that: comply with an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph if one exists, and the USP chapter on pharmacy compounding; are components of FDA-approved drug products ...

What is powder in pharmacy?

The term “powder” has more than one connotation in pharmacy. It may be used to describe the physical form of a material, that is, a dry substance composed of finely divided particles that may be used as the basis of many other solid dosage forms such as tablets, capsules, etc. Powders may also be used to describe a type ...

What are pharmaceutical powders?

A pharmaceutical powder is defined as a dry, solid substance, composed of finely divided drugs with or without excipients and intended for internal or external use. It is a solid substance in finely divided state typically obtained by crushing, grinding, or comminuting.

Why do pharmacists look for efflorescent powders?

When working with powders pharmacists should look out for efflorescent powders since they contain water of hydration, which may be released when the powders are triturated or are stored in an environment of low humidity. The water liberated can make the powder damp and pasty.

How are powders classified?

Powders can be broadly classified by the way they are presented/dispensed to the user into bulk powders and divided powders. Other classifications of powders are based on particle size and based on use.

What is divided powder?

Divided powders, or chartulae, are powders in which the individual dose has been packed separately. The traditional packing of divided powders is in wrapped paper. Volatile or hygroscopic drugs are wrapped in aluminium foil or plastic bags.

How to compound a syringe?

The following tips can be useful for pharmacists who need to do some compounding that involves powders: 1 A coffee grinder will aid in the size reduction of small amounts of powders. 2 Mixing powders of similar particle size and density can be done in a plastic bag. 3 A dust mask can be used to protect the dispenser if the powder is very light. 4 Powders that are too fluffy can be compacted by the addition of a few drops of alcohol, water, or mineral oil. 5 Magnesium stearate less than 1% can be added to increase the flow and lubrication of powders. 6 Sodium lauryl sulfate up to 1% can be used to aid the wetting and dissolution of the powder or to reduce the electrostatic forces created by handling the powder.

What is the particle size of a powder?

Properly prepared, powders have a uniform, small particle size (varying 10nm-1000μm) that has an elegant appearance. In general, powders are more stable than liquid dosage forms and are rapidly soluble, enabling the drug to be absorbed quickly.

Disadvantages of Pharmaceutical Powder

Drugs having bitter, nauseous, and unpleasant taste cannot be dispensed in powdered form.

General Method of Preparation

The crystalline substances are powdered separately and then weigh the required quantity of each ingredient.

What is bulk drug list?

The Food and Drug Administration (FDA or Agency) is withdrawing the proposed rule to list bulk drug substances used in pharmacy compounding and preparing to develop a list of bulk drug substances (bulk drugs) that may be used to compound drug products , although they are neither the subject of a United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drugs. To identify candidates for this bulk drugs list, interested groups and individuals may nominate specific bulk drug substances, and FDA is describing the information that should be provided to the Agency in support of each nomination.

When did the FDA withdraw the list of bulk drugs?

Therefore, the Agency withdraws the proposed rule, “List of Bulk Drug Substances That May Be Used in Pharmacy Compounding,” published in the Federal Register of January 7 , 1999 ( 64 FR 996 ).

When was the FDA banned from compounding?

These provisions were held unconstitutional by the U.S. Supreme Court in 2002. [ 1] . After the court decision, FDA suspended its efforts to develop the list of bulk drug substances that could be used in compounding. The Drug Quality and Security Act (DQSA) removes from section 503A of the FD&C Act the provisions that had been held unconstitutional ...

What is chemical grade?

Chemical grade or description of the strength, quality, and purity of the ingredient;

Who can nominate bulk drugs?

To identify candidates for this list, FDA is seeking public input in the form of specific bulk drug nominations. All interested groups and individuals may nominate specific bulk drug substances for inclusion on the list. After evaluating the nominations and, as required by section 503A, consulting with the USP and the Pharmacy Compounding Advisory Committee, FDA will issue the list as a regulation under notice-and-comment rulemaking procedures.

Does the FDA guarantee that all drugs nominated during the nomination period will be considered for inclusion on the next published bulk?

FDA cannot guarantee that all drugs nominated during the nomination period will be considered for inclusion on the next published bulk drugs list. Nominations received during the nomination period that are supported by the most complete and relevant information will likely be evaluated first.

Can a drug be compounded?

One of the conditions for such an exemption is that a drug product may be compounded if the licensed pharmacist or licensed physician compounds the drug product using bulk drug substances that: “ (I) comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding; (II) if such a monograph does not exist, are drug substances that are components of drugs approved by the Secretary; or (III) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, that appear on a list developed by the Secretary through regulations issued by the Secretary under subsection (d) [of Section 503A]” (section 503A (b) (1) (A) (i) of the FD&C Act).

Why is bulk powder dispensing bad?

The dispensing of bulk powders has a further disadvantage of dosage inaccuracy resulting from several fac-tors such as the BD of powder, consolidation during handling, and the method of measuring the dose by the patient. For these reasons, the dis-pensing of bulk powders is restricted to drugs with some dosage flexibility.

How are powders classified?

Powders as dosage forms can be classified based on their usage and/or phys-ical characteristics as detailed in Sections .

What is a reconstitution powder?

Powders for reconstitution into an oral solution or suspension are com-monly dispensed to the patient in multidose bottles. The pharmacist recon-stitutes the powder using water, and the patient is instructed to consume a defined dose, by volume, of the resulting suspension. This mode of drug dispensing is intended to minimize the effects of physical instability of the suspension and/or the chemical instability of the drug compound on storage. This dosage form is exemplified by amoxicillin powder for oral suspension.

What is effervescent powder?

Effervescent granules are sold as bulk powders intended for dispensing of a unit dose and reconstitution with water to form a solution by the patient immediately before administration. Upon contact with water, effervescence is produced by the reaction between an acidic component, such as succinic acid or tartaric acid, and a carbon dioxide-releasing basic component, such as sodium carbonate or bicarbonate. Effervescent granules must be kept in dry state to prevent this reaction before reconstitution by the patient.

What is the replacement for powders?

Although the use of powders as a dosage form has been replaced largely by the use of tablets and capsules in modern medicine.

What is dusting powder?

Dusting powders are intended for external, local application. The antibiot-ics in powder form for application to open skin wounds exemplify these.

Is compounding a good form of dispensing?

There are, however, disadvantages to extemporaneous compounding of powders as a dosage form. The preparation methods are time consuming and are generally not suitable for drugs that are highly potent, unpleasant tasting, or hygroscopic.

What is wholesale drug distributor?from fda.gov

Wholesale drug distributors are a link between manufacturers and health care professionals. Their role is to ensure prescription medications are delivered safely and efficiently to thousands of health care practitioners and pharmacies nationwide every day.

Why is it important to buy drugs from unlicensed sources?from fda.gov

It puts your patients at risk of consuming drugs that may be unapproved, counterfeit, contaminated, or ineffective. If you purchase drugs from illegal sources, you are breaking the law and you may be subject to criminal investigation.

What is bulk powder?

Bulk powders contain a mixture of all the materials, packed into a properly designed bulk containers, such as a glass or plastic bottle.

What is the major problem of bulk powders?

The major problem of bulk powders is the inaccuracy of dos e.

What is divided powder?

Divided powders are bulk powders in which the individual dose has been packed separately. The traditional packing of divided powders is in wrapped paper.

Why do you use dusting powder?

Dusting powders are usually dispensed in a relatively fine state (micronized) to increase efficacy and decrease irritation.

What is powder form?

When the term “ powder ” is referred to as a dosage form, it represents a formulation that is a mixture of powdered drug and excipients.

Is oral powder faster than capsules?

The dissolution rate of oral powders containing water-soluble drugs is generally faster than tablets or capsules, in which disintegration of the tablet or the capsule shell is required prior to dissolution.

Classification of Powders Based on Use

Classification of Powders Based on Particle Size

Classification of Powders Based on Dispensing

• Pharmaceutical powders are classified based on dispensing or by the way they are presented to the user into bulk or divided powders.

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