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OOS Investigation Tools: A Comprehensive Guide

Introduction In the pharmaceutical industry, Out-of-Specification (OOS) events can have significant consequences, impacting product quality, patient safety, and regulatory compliance. Effective OOS investigation is crucial to identify the root causes, implement corrective actions, and prevent future occurrences. This blog post will explore various tools and techniques employed in OOS investigations. Essential Tools for OOS Investigations Data Analysis Tools: Statistical Software: Leverage software like Minitab, Excel, or specialized statistical packages for data analysis, trend identification, outlier detection, and process variability assessment. Quality Management Systems (QMS): Utilize QMS software to centralize and manage quality data, facilitating efficient data retrieval, analysis, and reporting during investigations. Electronic Batch Records (EBR): Employ EBR systems to capture and store detailed manufacturing process information, aiding in tracing back steps, identifyi

Types of Dosage Forms

Types of Dosage Forms

In pharmaceuticals, there are so many dosage forms that we are used on daily basis. To know their presence, we will just go through the short definition of every dosage form.

1. Aerosols: 

Aerosols are dosage forms packed under pressure and contain therapeutic agents and propellants that are released upon actuation of the valve. After actuation, fine particles or droplet forms of dosage are released.

Types of Aerosols

  • Lingual aerosols
  • Topical aerosols


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Types of Dosage Forms

2. Capsules: 

Capsules are unit dosage forms in which the drug substance and or excipients are enclosed within a soluble container or a shell or coated in the capsule shell. The shells are composed of two pieces i.e. the body and a cap.

Types of capsules:

  • Hard-shell capsules- that are having gelatin.
  • Soft-shell capsules - generally have one piece the cells of capsules are usually made from gelatin or cellulose polymer or other suitable materials soft shell capsules For liquid formulations, modified release capsules, delayed-release capsules extended-release capsules are available.

3. Creams:

Creams are semisolid emulsion dosage forms. They often contain more than 20% water and volatiles. Topical cream contains less than 50% hydrocarbon waxes or polyols. As the vehicle for the drug substance generally intended for external application to the mucous membranes.

There are two types of formulations of cream water in oil emulsion and oil in water emulsion.

4. Emulsions:

Emulsions are dispersed colloidal systems consisting of two immiscible liquid phases. Generally, stabilizers with one or more suitable agents. Typically, Pharmaceutical emulsions are prepared from immiscible Aquarius and organic oil liquid Complexes. Multiple phases system may exist in an emulsion.

Types of Emulsion:

  • Water in oil: 

This dispersed phase typically ranges from 0.1 to 100-micrometer, these emulsions are OPEC whereas microemulsions are transparent or translucent and have dispersed in less than 0.1 micrometers. 

  • Oil in Water:

The emulsion may exhibit three types of instability phases i.e. flocculation, creaming, coalescence, etc. 

  • Flocculation in emulsions is when the emulsion droplets aggregate and thereby form larger units.
  • Coalescence are small droplets within the media continuously combined to form progressive larger droplets. 
  • Screaming where one of the phases migrates to the top or the bottom depending on the relative density of the two phases creams.

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5. Lotions:

A lotion is a low-viscosity topical preparation intended for application to the skin. By contrast, creams and gels have a higher viscosity, typically due to lower water content. Lotions are applied to external skin with bare hands, a brush, a clean cloth, or cotton wool.

While a lotion may be used as a medicine delivery system, many lotions, especially hand lotions, body lotions, and lotions for allergies are meant instead to simply smooth, moisturize, soften, and, sometimes, perfume the skin.

These lotions are sterile liquid dosage forms of drug substances dissolved or dispersed in a suitable emulsion medium. Injectable emulsions are for the parenteral administration of poorly water-soluble drugs.

 6. Suspension:

A pharmaceutical suspension is a coarse dispersion of insoluble solid particles in a liquid medium. The particle diameter in a suspension is usually greater than 0.5 µm. However, it is difficult and also impractical to impose a sharp boundary between the suspensions and the dispersions having finer particles. Suspensions are an important class of pharmaceutical dosage forms.

Whenever suspensions are prescribed note that, the suspension should be shaken well before use. This is to redisperse the entire suspension which may have settled down. Otherwise, there will be no effect.

7. Foams:

Foams are preparation that comprises gas bubbles distributed in the liquid. The liquid contained the drug substance and suitable experience these may be packed in a pressurized container or in the other special dispersing devices. 

These are intended for application to the skin or mucous membranes. Surfactants are used to ensure the distribution of the gas in the liquid and to stabilize the foam. Medicated foams have a semi-solid consistency and can be formulated to quickly break down into a liquid or to remain as a foam to ensure prolonged contact. Foams are intended to treat severely injured skin and they must be sterile.

8. Medical Gases

Medical gases are products that are administered directly as a gas and it is having pharmacological actions. Another medical gas was administered to the patient using a nasal mask or face mask, atmospheric tents, and endotracheal tubes for the pulmonary root. The dose of medical gas is typically given by a volume rate of flow under ambient temperature and pressure conditions. Administration of highly compressed gas generally requires a regulator to decrease the pressure, availability of volume flow controller, and suitable tubing to give the gas to the patient.

9. Gels: 

Gels are semisolids consistency either of suspension of small inorganic particles or of organic molecule interpenetrated by liquid jellies. Jellies are a type of gel that typically has higher water content. The gel can be classed either as a single-phase or two-phase system. Gels can be administered by topical or mucosal routes in veterinary medicines.

10. Granules:

Granules are solid dosage forms that are composed of an agglomeration of smaller particles. These are formed by the granulation process from fine powder or a solid that is wet granulation or dry granulation. These granules may be formulated for direct oral administration or used in tablet formulation by compression or field in a capsule or reconstructed with water to form a suspension or effervescent granules to liberate gas at the time of administration.

11. Medicated gums: 

Medicated gums are a reliable dosage form that is designed to be achieved the release of drug substances into saliva. Gums formulated from insoluble synthetic gums based such as polyisoprene, Polyisobutylene, polythene star gums extract for pliability softener or a plasticizer used such as oleak acid, propylene glycol. Two types of preparations one is melted gum and the second is directly compressed gums.

12. Implants:

Implants are long-acting dosage forms that provide continuous release of a drug substance of 1 for a period of months to years they are administered by the parenteral route. For systemic delivery, they may be placed subcutaneously or for local delivery, they can place in a specific region in the body.

13. Pastes:

Pastes are semisolid preparations having stiff consistency and contain a high percentage of finely dispersed solids. Pastes are intended for application to the skin oral cavity or a mucous membrane.

14. Inserts:

Inserts are solid dosage forms that are inserted into a naturally occurring non-surgical body cavity other than the mouth or rectum. The drug substance in the inserts is delivered for local or systemic action. Vaginal inserts are usually Global or over form.

16. Liquids: 

Liquids as a dosage form liquid consist of a pure chemical in its liquid state. Example Mineral oil, isoflurane. Dosage form terms are not applicable in the solutions.

17. Lozenges:

This is a unit oral solid dosage form designed to dissolve slowly in the mouth. They contain one or more drug substances. That is slowly liberated from the typical Flavoured and swallow. The sweetened base is useful for local action in the oral cavity or throat. Generally, formulation for antiseptic, analgesic, decongestant, antitussive, and antibiotic.

18. Pellets:

It is composed of small solid particles of a uniform shape sometimes called beads. Although the use of the term bids as a dosage form is not preferred. Administered by oral or by injection route.

19. Pills:

Pills are substances containing a small spherical solid body is intended for oral administration. The pill dosage forms have been largely replaced by compress tablets and by capsules.

20. Powders:

Powders are defined as a single solid or a mixture of a solid in a finely divided state.

21. Tablets: 

Tablet is a unit solid oral dosage form that is more widely used worldwide. Generally, it is in a compressed form containing drug substances and some excipients. Tablets are more preferred by doctors and patients too because of their advantages like it is easy to administer, it is stable, easy to carry, they maintain the accuracy of dosage form, it is economic, and many more advantages are there.

There are a few disadvantages also there for this dosage form like some drugs are not stable in compressed form.

There are many types of classification of tablets like according to route administration of dosage form.

Compressed tablets, Sustained release tablet, modified release tablet, Chewable Tablet, Coated tablets (Enteric-coated, Sugar coated, Film-coated), Dispersible tablet, buccal tablet, Sublingual tablet, effervescent tablet, etc.

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